Retsudvalget 2020-21
B 7
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Omskæring - PICO 2 Anæstesi
Omskæring - PICO 2 Anæstesi
Review information
Authors
Styrelsen for Patientsikkerhed
1
1
18-Dec-2019
[Empty affiliation]
Citation example: SfP. Omskæring - PICO 2 Anæstesi. Cochrane Database of Systematic Reviews [Year], Issue [Issue].
Characteristics of studies
Characteristics of included studies
Ahiskalioglu 2018
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
79 ± 2.90 years
Duration of surgey:
28.69 ± 6.17 min
kontrol 1
Age:
5 ± 3.31 years
Duration of surgey:
28.82 ± 5.56 min
Included criteria:
The study included a total of 140 ASA I-II children aged between 5and 12 years old who underwent
elective phimosis and circumcisionsurgery
Excluded criteria:
Children with severe systemic disease, previous neuro-logical or spinal disorder, coagulation anomaly,
allergy against local an-esthetics, local infection at blocksite or witha history of premature birthwere excluded from the study
Pretreatment:
There were no significant differences between the two groups interms of age, height, weight, ASA class,
and duration of operation
Interventions
Intervention Characteristics
Intervention 1
Description:
Caudal block was performed by ultrasound guided in Group U. Aftersterilization of the region and USG
with sterile plastic cover and gel, thesacral hiatus was visualized at the level of the sacral cornus at the out of plane
via the lineer transducer of Esaote MyLab30 (Florence, Italy) ul-trasound machineat18 MHz depth and gain was
adjusted tooptimal vi-sual quality (Fig. 2). When the inserted needle reached the center of theultrasound image, a
20 22 gauge caudal needle (Epican® Paed caudalB·Braun Melsungen AG) was inserted at the transverse view using
theout-of-plane technique (Fig. 3). After confirming the absence of anyblood or cerebrospinalfluid in the aspiration,
the caudal solution calcu-lated as0.5 ml/kg wasinjected with hemodynamic and ECG monitoring.
Dose:
Caudal solution was prepared as 0.125% levobupivacaine(Chirocaine 50 mg/10 ml ampule, Nycomed Pharma
AS, Norway) plus10 mcg/kg morphine (total volume: 0.5 ml/kg), and was administeredto both groups.
kontrol 1
Description:
Caudal block was performed in Group C by conventional method.The sacral cornus and the sacral hiatus
were palpated. After sterilizationof the region, a 20 22 gauge caudal needle (Epican® Paed caudalB·Braun
Melsungen AG) was inserted into the skin with a 60 80 degreeangle and until the sacrococcygeal ligament was
passed with a pop feeling (puncture of the sacrococcygeal ligament). Then, the angle oftheneedle wasreduced
to20 30 degrees and inserted further for an ad-ditional 2 3 mm, entering into the sacral canal. After confirming the
ab-sence of any blood or cerebrospinalfluid in the aspiration, the caudalsolution calculated as 0.5 ml/kg was injected
with hemodynamic andECG monitorin
Dose:
Caudal solution was prepared as 0.125% levobupivacaine(Chirocaine 50 mg/10 ml ampule, Nycomed Pharma
AS, Norway) plus10 mcg/kg morphine (total volume: 0.5 ml/kg), and was administeredto both groups.
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Reporting:
Fully reported
Direction:
Lower is better
Data value:
Endpoint
Adverse events
Outcome type:
DichotomousOutcome
Reporting:
Fully reported
Direction:
Lower is better
Data value:
Endpoint
Notes
One hundred-thirty four children, American Society of Anesthesiologists I-II, between the ages of 5 and 12, scheduled for
elective phimosis and circumcision surgery
Risk of bias table
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Omskæring - PICO 2 Anæstesi
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
18-Dec-2019
Quote: "agent was administered for pre-medication. <b>The patients were assigned to two
groups as the con- ventional caudal block (Group C) and the ultrasound-guided caudal block
(Group U) according to the randomization list by a computerized program.</b> Anesthesia
induction was performed via"
Judgement Comment: Randomisation list from a computerised program
Judgement Comment: No information on allocation concealment.
Judgement Comment: Blinding of personnel not possible (two different ultrasound guided
caudal block or conventional block groups). No information on blinding of patients.
Quote: "All datas are collected by an anesthetist blinded to the group classi cation."
Judgement Comment: Outcome assessor blinded
Judgement Comment: No patients discontinued. All patients randomised were included in the
analysis (no loss to follow up after randomisation)
Quote: "(ClinicalTrials.gov. identi er NCT03337191)."
Judgement Comment: Outcomes are reported as stated on clinicalTrials.gov.
Judgement Comment: The study seems to be free from other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
High risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Al Qahtani 2014
Methods
Participants
Interventions
Outcomes
Notes
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants
undergoing painful procedures. Cochrane Database of Systematic Reviews 2016, Issue 7. Art. No.: CD001069. DOI:
10.1002/14651858.CD001069.pub5.
RCT
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Allocation concealment (selection bias)
Low risk
Blinding of participants and personnel
(performance bias)
High risk
Blinding of outcome assessment (detection bias) High risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Unclear risk
Other bias
Low risk
Anouar 2016
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
30 ±3.12 months
Duration of surgey:
16 ± 2.4 min
Anesthesia duration:
22 ±2.2 min
intervention 2
Age:
Duration of surgey:
Anesthesia duration:
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Omskæring - PICO 2 Anæstesi
kontrol 1
Age:
25.2 ± 5 months
Duration of surgey:
17 ± 1.8 min
Anesthesia duration:
23 ±1.5 min
kontrol 2
Age:
Duration of surgey:
Anesthesia duration:
Overall
Age:
Duration of surgey:
Anesthesia duration:
18-Dec-2019
Included criteria:
ASA I (American society of anesthesiologists) unpremedicated children, aged from 1 to 5 years (g20
kg) and undergoing day-case male circumcision.
Excluded criteria:
Exclusion criteria were allergy to local anesthetic, genital malformation, past history of penile surgery,
preoperative incident and additional surgical procedure other than circumcision.
Pretreatment:
Demographic parameters were similar in both groups.
Interventions
Intervention Characteristics
Intervention 1
Description:
received 0.1 ml/Kg of bupivacaine 0.5% with 1g/kg of clonidine in each side. Dorsal penile nerve block
was performed in the operation room, with standard monitoring, under general anesthesia. General anesthesia was
induced with Sevoflurane 6% and maintained with sevoflurane 3% in oxygen /air gas flow.
Dose:
0.1 ml/Kg of bupivacaine 0.5% with 1g/kg of clonidine in each side.
Duration:
Follow-up time:
intervention 2
Description:
Dose:
Duration:
Follow-up time:
kontrol 1
Description:
received 0.1 ml/kg of bupivacaine 0.5 % with placebo in each side. dorsal penile nerve block was
performed in the operation room, with standard monitoring, under general anesthesia. General anesthesia was
induced with Sevoflurane 6% and maintained with sevoflurane 3% in oxygen /air gas flow.
Dose:
0.1 ml/kg of bupivacaine 0.5 % with placebo in each side
Duration:
Follow-up time:
kontrol 2
Description:
Dose:
Duration:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
Quote: "Each patient was randomly assigned to one of the two groups by drawing from a
sealed envelope."
Judgement Comment: Sequence generation is not described
Quote: "Each patient was randomly assigned to one of the two groups by drawing from a
sealed envelope."
Judgement Comment: Sealed envelope
Quote: "after the block was completed. <b>If, at the time of incision or during surgery, there
was a rise in the heart rate or respiratory rate of >25% from baseline, an intravenous bolus of
Alfentanyl (20 µg/kg) was given by an anesthetist, blinded to the injected solution in the
block.</b> As multimodal analgesia is the"
Judgement Comment: It is not clear if the patients were blinded however they state that it is a
double-blinded study and the syringes were labeled "DPNB study"
Allocation concealment (selection bias)
Low risk
Blinding of participants and personnel
(performance bias)
Low risk
Blinding of outcome assessment (detection bias) Unclear risk
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Omskæring - PICO 2 Anæstesi
Incomplete outcome data (attrition bias)
Unclear risk
18-Dec-2019
Quote: "CHEOPS score was inferior to 7 for all included patients during the first six post
operative hours. CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) was
significantly lower in group 1 from H2 to H24 in comparison with group 2 (Table 2)."
Judgement Comment: Total number of patients included in the analysis is not described.
Judgement Comment: No protocol
Quote: "The authors declare no competing interests."
Judgement Comment: No other sources of bias
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Arnett 1990
Methods
Participants
Interventions
RCT
52 male NB; FT; BW > 2000 g; 5 min Apgar scores >/= 6
0.4 ml lidocaine DPNB (n=23)
0.4 ml saline DPNB (n=22)
no treatment control (n=7)
WT not reported; mean length for entire procedure was 4.4 minutes
HR, infant irritability, O2sat
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
High risk
Unclear risk
Low risk
Support for judgement
Inadequate procedure: "The infants were divided by random selection through the use of cards
into three groups."
No information on allocation concealment
Likely the procedure (injection) was blinded for the operator and staff.
Likely nurses and surgeon grading the procecure were blinded. "Physicians could correctly
identify the anesthetized infant 81% of the time (17/21) and 100% of the infants that did not
receive anesthesia were correctly identified."
However unclear, 2-3 patients were excluded from analysis due to missing data points. No
analysis of the failure to analyze the patients in the group they were allocated. Not clear if any
droped out and not reffering to a flowchart
Nor reffering to a protocol but report on relevant outcomes No protocol however, data from all
time points are presented.
No reason to suspects other sources of bias.
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Awori 2019
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
16.9(7.3) years
Duration of surgey:
Anesthesia duration
:
intervention 2
Age:
Duration of surgey:
Anesthesia duration
:
kontrol 1
Age:
16.7(7.5) years
Duration of surgey:
Anesthesia duration
:
kontrol 2
Age:
Duration of surgey:
Anesthesia duration
:
Overall
Age:
Duration of surgey:
Anesthesia duration
:
Included criteria:
We recruited men and boys 10 years of age and above. To be eligible, participants needed to be
uncircumcised, in good general health and free of any active sexually transmitted infections.
Excluded criteria:
Participants with known sensitivity to injectable lidocaine or topical cream, or a congenital abnormality
or other condition which in the opinion of the medical staff prevented safe participation in the study were excluded
Pretreatment:
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Omskæring - PICO 2 Anæstesi
Interventions
18-Dec-2019
Intervention Characteristics
Intervention 1
Description:
Up to 5 grams of a cream containing 2.5% prilo-caine and 2.5% lidocaine were applied to participants in
the TA group ,who were then asked to rest as the anaesthesia took effect.
Dose:
5 grams of a cream containing 2.5% prilo-caine and 2.5% lidocaine
Duration:
Follow-up time:
intervention 2
Description:
Dose:
Duration:
Follow-up time:
kontrol 1
Description:
Participants assigned to the IA group underwent dorsal penile nerveblock with a penile shaft ring block,
using 1% lidocaine without epinephrine
Dose:
1% lidocaine without epinephrine
Duration:
Follow-up time:
kontrol 2
Description:
Dose:
Duration:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Styrelsen for Patientsikkerhed Britta Bjerrum Mortensen
on 08/10/2019 20:42
Select
Kirsten: Suppl. - klik på link i View Fulltext
Britta Tendal
on 15/10/2019 16:45
Select
Raw data available
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
Quote: "IA during their ShangRing circumcision. <b>We used age stratified block
randomisation with varying block sizes in a 2:1 ratio (TA:IA). The random allocation sequence
was computer generated by a researcher unaffiliated with the study.</b> In each treatment
group, we"
Judgement Comment: Computer generated.
Judgement Comment: Computer generated by a researcher unaffiliated with the study. Not
described
Judgement Comment: One group received topical and the other injectable anaesthesia. Not
possible to blind personnel
Quote: "are shown in Table 1. <b>The primary outcome measure was pain, as reported by
participants, at various points around the time of circumcision. We used the 11-point visual
analogue scale that ranged from 0 = no pain to 10 = worst pain possible.</b> Secondary
outcomes included procedure time,"
Judgement Comment: self-reported pain
Quote: "total of 16 participants were lost to follow-up; 12 (5.3%) in the TA and 4 (3.4%) in the
IA group."
Judgement Comment: Reasons for loss to follow up not stated.
Judgement Comment: Outcome as reported in protocol. Protocol at clinicaltrials.gov
Judgement Comment: The study seem to be free from other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
High risk
Blinding of outcome assessment (detection bias) High risk
Incomplete outcome data (attrition bias)
High risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Benini 1993
Methods
Participants
Interventions
RCT
28 male NB; FT; BW > 2500g; 5 min Apgar > 7; < 7 d age
0.5 ml (0.5g) LP cream (n=14)
0.5 ml (0.5 g) petroleum jelly (n=14)
applied and covered with occlusive dressing 45 - 60 min prior
HR, O2sat, % time crying, facial action
Outcomes
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Omskæring - PICO 2 Anæstesi
Notes
18-Dec-2019
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Unclear risk
Unclear risk
Unclear risk
Support for judgement
Only stated the newborns were randomized. No information about sequence generation
No information about allocation concealment.
No information about blinding of specific personnel or parents. The application of EMLA or
sterile petroleum jelly described (but not who applied) and likely the pediatrician were blinded.
Blinded outcome assessor evaluating facial expressions and crying. Cyring was recorded
usind a microphone.
One newborn excluded post follow up.
No protocol however relevant and thorough outcomes reported
No reasons to suspect other sources of bias.
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Beyaz 2011
Methods
Participants
RCT
50 male children
DPNB, n=23, age: 8.5yr (SD:3.5)
Caudal, 0.5 ml/kg.), n=24, 7.4yr (SD:3.1)
DPNB (0.25% levobupivacaine, 0.5 ml/kg.)
Caudal block (0.25% levobupivacaine, 0.5 ml/kg.)
Flacc Pain Scale, analgesic amounts, times, and probable local or systemic complications were recorded.
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Low risk
Unclear risk
Support for judgement
SUPPORTING ANNOTATIONS: "Patients were randomized by the closed-envelope technique
into 2 groups."
SUPPORTING ANNOTATIONS: "Patients were randomized by the closed-envelope technique
into 2 groups."
SUPPORTING ANNOTATIONS: "Drug solutions were prepared by another anesthetist."
COMMENTS: "No information about blinding."
COMMENTS: "No information about blinding."
SUPPORTING ANNOTATIONS: "In the recovery room, all children were observed and
recorded for pain, sedation, and side effects (nausea, vomit, agitation, penile hematoma,
bleeding, motor block, urinary retention) at 5, 15, and 30 minutes. Then, the children were
transferred to wards. They were observed and recorded for the same parameters at 1, 3, and
6 hours."
COMMENTS: "No information who monitored the outcomes nor how in terms of blinding."
SUPPORTING ANNOTATIONS: "Two patients in group 1 and 1 patient in group 2 were
excluded from the study."
COMMENTS: "Excluded due to need of extra analgesic Rx."
COMMENTS: "No protocol however. Outcomes marginally reported (Fig. 1 and 2 identical?)
Not reffering to a protocol but report on relevant outcomes"
COMMENTS: "No reasons to suspect other sources of bias."Other bias
Blinding of outcome assessment (detection bias) High risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Blass 1991 A
Methods
Participants
Interventions
RCT
30 male NB, FT; 28 - 54 h age; Apgars > 8
1.5 ml 24% sucrose by nipple
1.5 ml water by nipple
no treatment control
*comparison is sucrose versus water (placebo)
number subjects per group not specified
3 min WT after intervention
% time crying
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
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Omskæring - PICO 2 Anæstesi
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
18-Dec-2019
Sequence generation not described in details. Each infant was randomly assigned to a
treatment condition (water vs sucrose) and brought in his or her own bassinet to a quiet corner
of the nursery for testing
No information
everal bottles of sterile water or 24% sucrose solution were prepared daily and marked to
ensure that neither experimenter nor physician knew of their contents.An experi- enced nurse
who was unaware of infant treatment then collected blood in her usual manner using standard
methods of heel lancing. Likely relevant personnel were blinded.
Trained research assistants who were unaware of syringe contents scored the videotapes and
meas- ured crying duration during blood collection and the immediate 3-minute recovery
period. Crying was defined as audible crying vocalizations.
An experi- enced nurse who was unaware of infant treatment then collected blood in her usual
manner using standard methods of heel lancing. Trained research assistants who were
unaware of syringe contents scored the videotapes and meas- ured crying duration during
blood collection and the immediate 3-minute recovery period. Crying was defined as audible
crying vocalizations. There was virtually no disagreement among coders in recognizing crying
Outcome assessors were likely blinded.
No information
Not reffering to a protocol but report on relevant outcomes.
The study seems free of other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Blass 1991 B
Methods
Participants
Interventions
RCT
30 male NB, FT; 28 - 54 h age; Apgars > 8
1.5 ml 24% sucrose by nipple
1.5 ml water by nipple
no treatment control
*Comparison is sucrose versus no treatment
number subjects per group not specified
3 min WT after intervention
% time crying
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Low risk
Low risk
Unclear risk
Low risk
Low risk
Support for judgement
See Blass 1991 A
See Blass 1991 A
See Blass 1991 A
See Blass 1991 A
See Blass 1991 A
See Blass 1991 A
See Blass 1991 A
Bramwell 1982
Methods
Participants
RCT
90 inpatients aged 1-12 years having elective circumcision.
Exclusions: caudal contra-indicated e.g. spina bifida, local sepsis.
Setting: UK
CAUDAL versus PARENTERAL
Caudal (n = 46 ) 0.25% bupivacaine 0.5 ml/kg up to 40 ml (0.1875% used for volumes over 40 ml).
Parenteral analgesia (n = 45): Dihydrocodeine 1 mg/kg IM after induction of anaesthesia and prior to
surgery.
Pain: Two 8-cm linear analogue scales were marked by a nurse every 5 minutes for 30 minutes and then
every 15 minutes for the next 90 minutes, indicating the patient's level of pain from none to severe and
level of consciousness (unrousable to alert), respectively.
Rescue analgesia (dihydrocodeine 1mg/kg) was administered in the first 2 hours after surgery as needed
at the nurses' discretion.
Other outcomes: Vomiting, drinking, administration of analgesics and weakness.
Interventions
Outcomes
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Omskæring - PICO 2 Anæstesi
Notes
18-Dec-2019
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
High risk
Support for judgement
Each patient was allocated by random numbers to the analgesic or to the caudal group. The
two groups were similar in age and weight
No information on allocation concealment
No information on blinding of participants and personnel
lthough the chart did not show which analgesic the patient had received, this information was
available on the ward so that any complication could have been dealt with quickly.The nursing
staff had participated in the design of this chart and had been instructed in its use.
statistical calculations were based on the true number of readings.COMMENTSIt is not stated
how many were excluded from analysis due to the nurse allocated elsewhere. Per protocol
analysis.
Not reffering to a protocol, but report on relevant outcomes
No reasons to suspect other sources of bias.
Blinding of outcome assessment (detection bias) High risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Butler O'Hara 1998
Methods
Participants
Interventions
RCT
50male infants inNICU; >/= 34.5 weeks (post-menstrual) at time of circumcision and stable for discharge
participants were 3 -105 days age at time of circumcision
0.5 ml (0.5g) LP cream (n=25)
0.7 - 1.0 ml lidocaine DPNB + placebo cream (n=25)
creams applied 60 min prior and covered with occlusive dressing
3 min WT after DPNB
HR; RR; NIPS score (primary outcome)
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
Low risk
Support for judgement
computerized randomization was performed by a randomized number generator in blocks of
10.
Insufficient information on allocation concealment
to assure that the bedside nurse remained blinded to group assignment, every infant had a
cream and dressing applied to the penis 1 hour before the circumcision.
the videotapes were then reviewed by a second individual (C.L.) unaware of the in- fant s
experimental group assignment. NIPS scores were assigned for each of the six events on all
44 randomized.
4 infants were excluded from the EMLA group and 2 infants from the DPNB due to technical
difficulties with the recording equipment.
No reference to study protocol, but appears to report on all outcomes of interest
The study appears to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Canakci 2017
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
6.05±13.1 years
Duration of surgey:
20.7±3.5 min
Anesthesia duration
:
intervention 2
Age:
9.62±11.6 years
Duration of surgey:
19.5±2.5 min
Anesthesia duration
:
kontrol 1
Age:
8.82±7.6 years
Duration of surgey:
19.8±3.1 min
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Omskæring - PICO 2 Anæstesi
Anesthesia duration
:
kontrol 2
Age:
Duration of surgey:
Anesthesia duration
:
Overall
Age:
Duration of surgey:
Anesthesia duration
:
18-Dec-2019
Included criteria:
ASA I physical status without any additional disorders
Excluded criteria:
Children or parents who did not accept our analgesia techniques when explained to them were
excluded. Likewise,those who also had some additional urological problems such as paraphimosis reduction, hypospadias
repair, epispadias repair, undescended testicles surgery; and who were planned to be operated for those reasons and to
be circumcised at the same time were al so excluded. And so were patients who had allergy against
localanaestheticsoropioidsorthosewithatendencytohaveallergies.AlsoexcludedwerechildreninASAII/IIIphysicalstatussufferin
gfromadditionaldisorderssuchaschildhoodasthma,diabetes,epilepsy, liverdisease, congenital hear tdiseaseetc.;children
who had bleeding, coagulation disorders or haematological problems such as anaemia; morbidly obese children with body
weight above the 90th percentile according to the percentile curves; children diagnosed with growth development
retardation under the 3rd percentile according to the percentile curves; children diagnosed with some additional
endocrinological problems;children who were followed by a paediatric psychiatrist and taking medication for any mental
health problem like attention deficit hyperactivity syndrome,depression etc.;children with neurological,neuromuscula
rdisorders;and children out side the 6-12age bracket.
Pretreatment:
Interventions
Intervention Characteristics
Intervention 1
Description:
group M: Following standard general anaesthesia, 100mcg/kg of subcutaneous morphine was injected
into the deltoid muscle by means of a 26-gauge insulin needle.
Dose:
100 mcg/kg
Duration:
Follow-up time:
24 hours postoperative
intervention 2
Description:
dorsal penile nerve block with 1mg/kg of bupivacaine 0.25%
Dose:
Injecting bupivacaine 0.25% in 1mg/kg dose (maximum upper limitis 50mg)
Duration:
Follow-up time:
24 hours postoperative
kontrol 1
Description:
Group C: caudal block with bupivacaine 0.25% in a total volume of 0.50ml/kg in lateral position
Dose:
Bupivacaine 0.25% of 0.5 ml/kg volume in 1mg/kg dose (maximum 50mg, 20cc volume) was administered by
the anaesthesiologist into the sacral hiatus by means of a 22-gauge caudal needle.
Duration:
Follow-up time:
24 hours postoperative
kontrol 2
Description:
Dose:
Duration:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors'
judgement
Unclear risk
Unclear risk
High risk
Unclear risk
Low risk
Low risk
Low risk
Support for judgement
Quote: "The selected sample was randomised into 3 equal groups: DP, C and M. All the"
Judgement Comment: Sequence generation not described
Judgement Comment: Allocation concealment not described
Judgement Comment: Not possible to blind personnel
Judgement Comment: Blinding of outcome assessors not stated
Judgement Comment: All cases included in analysis. Loss to follow up not described
Judgement Comment: Not reffering to a protocol, however it seems like the report on all
relevant outcome
Quote: "Conflict of Interest: None."
Judgement Comment: The study seems to be free from other sources of bias
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Omskæring - PICO 2 Anæstesi
Concha 1994
Methods
Participants
RCT
18-Dec-2019
40 boys, mean age 4.7 years in caudal group and 5.6 years in fentanyl/rectal acetaminophen group, undergoing
day surgery for circumcision.
Setting: Chile
CAUDAL versus RECTAL/IV
Caudal: 0.25% bupivacaine 0.5 ml/kg (n = 20).
Rectal/IV: Fentanyl 2 ug/kg IV after induction, and rectal acetaminophen 15 mg/kg (n = 20), repeated
during 6 postoperative hours.
All children received the same general anaesthetic.
Episodes of nausea and vomiting,
passing of urine,
quality of pain relief on a visual analogue scale, all measured by anaesthetist.
Extra dose of acetaminophen given at anaesthetist's discretion.
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
Unclear (Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of
postoperative pain relief for circumcision in boys. Cochrane Database of Systematic Reviews
2008, Issue 4. Art. No.: CD003005)
Unclear (Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of
postoperative pain relief for circumcision in boys. Cochrane Database of Systematic Reviews
2008, Issue 4. Art. No.: CD003005)
Cited from Cyna et al. 2008: "In both White 1983 and Concha 1994 an anaesthetist assessed
the need for analgesia postoperatively and was apparently blinded to the technique, however
it is unclear as to whether the patients (or parents) were aware of the type of analgesia used."
(Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of
postoperative pain relief for circumcision in boys. Cochrane Database of Systematic Reviews
2008, Issue 4. Art. No.: CD003005)
Cited from Cyna et al. 2008: "In both White 1983 and Concha 1994 an anaesthetist assessed
the need for analgesia postoperatively and was apparently blinded to the technique, however
it is unclear as to whether the patients (or parents) were aware of the type of analgesia used."
(Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of
postoperative pain relief for circumcision in boys. Cochrane Database of Systematic Reviews
2008, Issue 4. Art. No.: CD003005)
Not reported. No ITT. (Please see Cyna AM, Middleton P. Caudal epidural block versus other
methods of postoperative pain relief for circumcision in boys. Cochrane Database of
Systematic Reviews 2008, Issue 4. Art. No.: CD003005)
Unclear
Unclear
Allocation concealment (selection bias)
Unclear risk
Blinding of participants and personnel
(performance bias)
Unclear risk
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Other bias
Unclear risk
Unclear risk
Dixon 1984
Methods
Participants
Interventions
31 male NB, FT, AGA, < 7 days age, > 2500 gm, 5 min Apgar > 7
0.8 ml lidocaine DPNB (n=15)
0.8 ml saline DPNB (n=8)
no treatment control (n=8)
4 - 5 min WT
Brazelton Neonatal Assessment Scale
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
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Omskæring - PICO 2 Anæstesi
Other bias
Unclear risk
18-Dec-2019
Dostbil 2014
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
7.9±2.1
Duration of surgey:
24.6±4.2
Anesthesia duration
:
intervention 2
Age:
7.8±1.9
Duration of surgey:
25.5±4.9
Anesthesia duration
:
kontrol 1
Age:
8.0±1.9
Duration of surgey:
25.5±5.3
Anesthesia duration
:
kontrol 2
Age:
Duration of surgey:
Anesthesia duration
:
Overall
Age:
Duration of surgey:
Anesthesia duration
:
Included criteria:
Two hundred and forty patients who were between the ages of 5 and 12 years, of American Society of
Anesthesiologists class 1 to 2 and scheduled for circumcision were included in the study
Excluded criteria:
Patients who had severe systemic disease, a previously known neurologic or spinal disease, bleeding
diathesis, amide-type local anaesthetic allergy, local skin site infection, family history of postoperative nausea and vomiting
(POnV) or motion sickness, or chronic upper airway obstruction and habitual snoring, were excluded from the study
Pretreatment:
No differences at baseline
Interventions
Intervention Characteristics
Intervention 1
Description:
The sacral hiatus was located using an aseptic technique, and a 25-gauge needle advanced
approximately 3 to 4 mm into the epidural space. After the negative aspiration of blood or cerebro-spinal fluid, 0.125%
levobupivacaine (volume 0.5 ml/kg) was injected, with the addition of 7.5, 10 or 15
g/kg
morphine
Dose:
7,5
g/kg
morphine
Duration:
Follow-up time:
intervention 2
Description:
The sacral hiatus was located using an aseptic technique, and a 25-gauge needle advanced
approximately 3 to 4 mm into the epidural space. After the negative aspiration of blood or cerebro-spinal fluid, 0.125%
levobupivacaine (volume 0.5 ml/kg) was injected, with the addition of 7.5, 10 or 15
g/kg
morphine
Dose:
10
g/kg
morphine
Duration:
Follow-up time:
kontrol 1
Description:
The sacral hiatus was located using an aseptic technique, and a 25-gauge needle advanced
approximately 3 to 4 mm into the epidural space. After the negative aspiration of blood or cerebro-spinal fluid, 0.125%
levobupivacaine (volume 0.5 ml/kg) was injected, with the addition of 7.5, 10 or 15
g/kg
morphine
Dose:
15
g/kg
morphine
Duration:
Follow-up time:
kontrol 2
Description:
Dose:
Duration:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Jeanett Rohde
on 23/10/2019 18:18
Select
Er det ok at populationen er Two hundred and forty patients who were between the ages of 5 and 12 years, of
AmericanSociety of Anesthesiologists class 1 to 2
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Omskæring - PICO 2 Anæstesi
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
18-Dec-2019
Quote: "This randomised, double-blind, three-arm con- trolled clinical trial"
Quote: "Patients were divided into three equal groups according to the random- isation list
created using a computer-based random- isation program."
Judgement Comment: Computer-generated
Judgement Comment: Allocation concealment not described
Quote: "After loss of consciousness, children were placed in the lateral position and caudal
block was performed by one of two anaesthetists experienced in this field, who did not know
which caudal study solution was used."
Judgement Comment: Personnel and patients were blinded
Quote: "The pain scores of each child were assessed by an independent blinded observer
using the Wong-Baker FACeS Pain rating Scale from 0 to 5 (0=no pain, 1=hurts a little bit,
2=hurts a little more, 3=hurts even more, 4=hurts a whole lot, 5=hurts worst) 7. This scale was
also explained to the family or guardian of the child so that observations could be continued at
home."
Judgement Comment: Pain was obtained by a blinded observer.
Quote: "All patients completed the study and there were no significant differences between
groups in terms of age, weight and duration of surgery"
Judgement Comment: I flowchartet er der dog 1 patient, der falder fra i "Group 7,5", og 2
patienter falder fra i "Group 10" på grund af "protocol violations".
Judgement Comment: Not possible to check registration but relevant outcomes are reported
Judgement Comment: The study seem to be free from other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Garry 2006
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1 (DPNB group)
Age:
39.3 weeks (SD: 1.0)
Duration of surgery:
Anesthesia duration:
Intervention 2
Age:
Duration of surgery:
Anesthesia duration:
Control 1
Age:
Duration of surgery:
Anesthesia duration:
Control 2 (Lidocaine-prilocaine)
Age:
39.2 weeks (SD: 0.89)
Duration of surgery:
Anesthesia duration:
Overall
Age:
Duration of surgery:
Anesthesia duration:
Included criteria:
Over a 3-week period, 18 term male newborns were recruited forstudy participation after parental
consent was obtained for avideotaped circumcision
Excluded criteria:
viewing process might have been a potential confounding variable.Exclusion criteria for the newborns
were a gestational age <37weeks, any contraindication to circumcision, use of sedative or painmedication, and parental
refusal to participate.
Pretreatment:
Interventions
Intervention Characteristics
Intervention 1
Description:
Group 1 was six newborns undergoing circumcisionafter a dorsal penile nerve block.The dorsal penile
nerve block was performed with0.3 0.5 ml of 1% lidocaine injected at 2 and 10 o clock positionsat the base of the
penis 5 min before the procedure.
Dose:
0.3 0.5 ml of 1% lidocaine injected
Follow-up time:
Intervention 2
Description:
Group 2 was six newbornsundergoing circumcision after topical lidocaine prilocaine.A topicalmixture of
lidocaine (2.5%) and prilocaine (2.5%) cream (EMLAanesthetic cream, AstraZeneca Pharmaceuticals, Wilmington,
DE,USA) was applied to the shaft of the penis with an occlusivedressing 1 h before the procedure.
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Omskæring - PICO 2 Anæstesi
Dose:
lidocaine (2.5%) and prilocaine (2.5%) cream
Follow-up time:
18-Dec-2019
Control 1
Description:
Group3 was six newborns undergoing a sham procedure with threehaving dorsal penile nerve block and
three having topicallidocaine prilocaine.A sham procedure was administration of anesthesia with theusual draping
followed by gentle manipulation with touch and nocircumcision performed. The neonates undergoing the
shamprocedures had the circumcision performed immediately after thevideotaping was completed. A randomized
listing was followed fordetermination of the sham procedure versus the actualcircumcision.
Dose:
Follow-up time:
Control 2
Description:
Dose:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
Quote: "with the circumcision procedure. Methods <b>The study was a prospective,
randomized, reviewer blinded comparison of anesthetic methods used in neonatal male
circumcision.</b> The Institutional Review Board approved"
Judgement Comment: Not described in details how sequence generation was perfomed
Judgement Comment: No information of concealment of the allocation sequence
Quote: "1 h before the procedure. <b>A sham procedure was administration of anesthesia
with the usual draping followed by gentle manipulation with touch and no circumcision
performed. The neonates undergoing the sham procedures had the circumcision performed
immediately after the videotaping was completed. A randomized listing was followed for
determination of the sham procedure versus the actual circumcision.</b> This divided the
neonates into"
Judgement Comment: No blinding of participants and personel
Evaluater was blinded
Judgement Comment: No missing data
Judgement Comment: No protocol available, no signs of selective reporting
Judgement Comment: The study apperas to be free of other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
High risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Gauntlett 2003
Methods
Participants
Interventions
RCT
60 boys aged 1 to 10 years undergoing elective circumcision.
Exclusions: contraindications to either type of block or parental inability to assess pain scores.
CAUDAL versus DNBP
Caudal (n = 30) 0.5 ml/kg bupivacaine 0.15% with ketamine 0.5 mg/kg:
DNBP (n = 30); bupivacaine 0.5%, 3-5 ml according to age.
Children were not premedicated other than with EMLA cream applied to the back of their hands.
GA: IV propofol or inhalation of sevoflurane in nitrous oxide and oxygen as clinically appropriate.
Anaesthetic maintenance was with nitrous oxide, oxygen and sevoflurane.
All local anaesthetic procedures were performed by one experienced paediatric anaesthetist.
Children were not premedicated other than with EMLA cream applied to the dorsum of both hands.
Rescue analgesia (as time to paracetamol - could not be used in meta-analysis, number of failed blocks
used to measure this)
Failed blocks
Motor weakness (scale of 0-4)
Nausea and vomiting (including severe PONV)
Eating disturbance
Sleep disturbance
Behavioural disturbance
Urinary retention
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Outcomes
Notes
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Omskæring - PICO 2 Anæstesi
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Unclear risk
Unclear risk
High risk
Support for judgement
18-Dec-2019
After induction of anaes- thesia, patients were randomly allocated into one of two
groups.Sequence generation not clearly described
No information on allocation concealment
Personnel was not blinded
Parents and ward nurses were blinded to which of the blocks the boys received by small spot
dressings applied below the symphysis pubis and over the sacrococcygeal membrane, to
conceal the injection site. Parents were asked not to disturb the dressing for 24 h. They were
told that the local anaesthetic may cause some motor weakness, and the nurses on the
paediatric day ward were instructed not to discuss any details of the two kinds of block with
parents.
there were three failed blocks in the caudal group and none in the DNB group. These were
excluded from subsequent analysis. For one child in the caudal group, the time taken to first
dose of paracetamol was recorded on the data chart incorrectly (the time recorded was earlier
than the time the block was given), and his data set was excluded from analysis of time to first
analgesia There were three failed blocks in the caudal group and none in the DNB group.
These were excluded from subsequent analysis. For one child in the caudal group, the time
taken to first dose of paracetamol was recorded on the data chart incorrectly (the time
recorded was earlier than the time the block was given), and his data set was excluded from
analysis of time to first analgesia
No protocol (no heart rate, oxygen saturation)
The study seems to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Gulec 2015
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
Duration of surgey:
Anesthesia duration
:
intervention 2
Age:
Duration of surgey:
Anesthesia duration
:
kontrol 1
Age:
Duration of surgey:
Anesthesia duration
:
kontrol 2
Age:
Duration of surgey:
Anesthesia duration
:
Overall
Age:
Duration of surgey:
Anesthesia duration
:
Included criteria:
60 ASA physical status I-II children, aged between 3 and 9 years, undergoing circumcision operations
under sedation were recruited according to a randomize and double-blind institutional review board-approved protocol.
Excluded criteria:
Patients with clinically significant neurological, respiratory, cardiovascular and psychiatric diseases
were excluded from the study
Pretreatment:
Interventions
Intervention Characteristics
Intervention 1
Description:
mixture of midazolam 0.05 mg/kg+ketamine3mg/kg+atropine 0.02mg/kg intra muscular lyinthe presence
of parents in the pre-operative holding area. Patients were induced with propofol---ketamine in Group I
Dose:
Duration:
Follow-up time:
intervention 2
Description:
Dose:
Duration:
Follow-up time:
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
kontrol 1
Description:
mixture of midazolam 0.05 mg/kg+ketamine3mg/kg+atropine 0.02mg/kg intra muscular lyinthe presence
of parents in the pre-operative holding area. Patients were induced ketamine alone in Group II.
Dose:
Duration:
Follow-up time:
kontrol 2
Description:
Dose:
Duration:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Jeanett Rohde
on 16/10/2019 16:32
Select
Population: physical status I---II children
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Low risk
Low risk
Support for judgement
Quote: "Patients were randomized into two groups via sealed envelope assignment."
Quote: "Patients were randomized into two groups via sealed envelope assignment. Both
groups"
Judgement Comment: Double-blinded and the knowledge of the intervention is not likely to
influence (measured) outcomes
Judgement Comment: Double-blinded and the knowledge of the intervention is not likely to
influence (measured) outcomes
Judgement Comment: Insufficient information on missing data
Judgement Comment: No reference to study protocol, but appears to report on outcomes of
interest
Quote: "The authors declare no con icts of interest."
Judgement Comment: The study appears to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Haliloglu 2013
Methods
Participants
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
Unclear risk
Support for judgement
SUPPORTING ANNOTATIONS: "Randomization was performed by NCSS software from a
single centre."
COMMENTS: No information on allocation concealment
COMMENTS: Unclear if personnel were blinded.
SUPPORTING ANNOTATIONS: "CHEOPS scores were measured by a single nurse at each
hospital. Physicians performing the penile or caudal block were not involved in CHEOPS score
measurement."
SUPPORTING ANNOTATIONS: "159 patients were evaluated. <b>Seven patients were
excluded from the study. In 4 of these patients cardiac arrythmia was observed during
anesthesia induction and their circumcisions were postponed. In the other 3 patients laryngeal
spasm developed after the procedure and as anesthesia resolution was delayed in these
patients, their pain scoring was tought to have been effected so they were excluded."
COMMENTS: No protocol, however stated primary and secondary outcomes reported. Still
limited reporting, as they inlude no variations (SD/SEM/CI)
COMMENTS: No reasons to suspect other sources of bias
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
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Omskæring - PICO 2 Anæstesi
Hardwick Smith 1998
Methods
Participants
Interventions
RCT
40 male NB; FT; Apgar >/= 7; 6 hr - 5 days age; fasting 30 -120 min prior; normal exam
1.0 ml 5% lidocaine RB (n=20)
no treatment control (n=20)
3 min WT
HR; RR; O2sat; behavioral state; cry time
18-Dec-2019
Outcomes
Notes
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
Infants were comparable in terms of demographic data (Table 1), fasting time, baseline vital
signs, and behav- ioral state (Table 2). There was no significant difference in the procedure
duration with or without anesthesia (10.43 1.29 minutes for the anesthetized group versus 9.7
1.05 minutes for controls).newborns undergoing circumcision were assigned.
randomly through drawing of cards to receive either ring block (n 20) or no anesthesia (n 20).
Admission criteria included 37 42
No information on allocation concealment
ing block then was performed by a single oper- ator using 1 mL of 0.5% lidocaine without
epinephrine, delivered subcutaneously and circumferentially at the base of the penis with a
25-gauge needle (Figure 1). After a 3-minute waiting period, circumcision was performed by
the same operator using a Gomco clamp.
ndices of perceived pain including behavioral state, heart rate, respiratory rate, and oxygen
saturation were recorded by one of several trained assistants at baseline (2 minutes after
monitors were applied), at ten intervals during the procedure, and 2 hours
postoperatively.Eight observ- ers assigned behavioral states to the recorded infants,Heart and
respiratory rates were monitored continu- ously using an apnea-bradycardia monitor
During certain portions of the procedure, oxygen saturation was not recorded in up to 50% of
the infants. A trend toward greater oxygen desaturation in the control group was
present.COMMENTSLikely no deviations or drop outs from groups.
No protocol. Apparently thorough outcome reporting.
No reasons to suspect other sources of bias.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
High risk
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Herschel 1998
Methods
Participants
Interventions
RCT
120 male NB; FT; > 2500g; Apgar >/= 8 at 5 min; >/= 12 hr age
0.8 ml 1% lidocaine DPNB (n=40)
10 ml 50% oral sucrose via nipple (n=40)
no treatment control (n=40)
3 min WT for DPNB; 2 min WT for sucrose group
HR; O2sat (%)
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants
undergoing painful procedures. Cochrane Database of Systematic Reviews 2016, Issue 7. Art. No.: CD001069. DOI:
10.1002/14651858.CD001069.pub5.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.Please see
Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn
infants undergoing painful procedures. Cochrane Database of Systematic Reviews 2016,
Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Allocation concealment (selection bias)
High risk
Blinding of participants and personnel
(performance bias)
High risk
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Omskæring - PICO 2 Anæstesi
Blinding of outcome assessment (detection bias) Low risk
18-Dec-2019
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Unclear risk
Other bias
Low risk
Holliday 1999
Methods
Participants
Interventions
RCT
50 male preterm/low birthweight NICU patients, subjects weighed 1600 to 2500g at time of circumcision 25-27 days age,
36 week GA at circumcision
0.8 ml 1% lidocaine DPNB + placebo cream (n= 19)
LP cream (n=12) (group enrollment stopped, excluded from data analyses)
placebo cream (n=19)
DPNB 5 min WT
cream applied 1 hr prior and covered with occlusive dressing
HR, RR, O2sat, systolic BP, behavioral score, serum B-endorphin
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
Low risk
Support for judgement
After informed consent was obtained, infants were randomized, using randomization tables, to
the DPNB, EMLA, or control group.
Insufficient information on allocation concealment
To maintain the blinded nature of the study, the DPNB and control groups received placebo
(acid mantle) cream and the EMLA group received EMLA cream.COMMENTSVery likely
relevant personnel are blinded
The investigator (M.H. or S.K.) monitoring the infant s physi- ologic variables and behavior
was not present during ap- plication of the placebo or EMLA cream or during admin- istration
of the DPNB injection.COMMENTSVery likely outcome assessors were blinded.
the institutional review board requested discon- tinuation of EMLA enrollment, and the study
contin- ued with only the DPNB and control groups. Because of the small number of patients in
the EMLA group, no meaningful statistical comparisons could be made, and these patients
were excluded from further analysis.COMMENTSNo analysis of the effect of not analysing the
group excluded. Likely all outcome data are available for the remaining groups.
No reference to study protocol, but appears to report on outcomes of interest No protocol
available. Post hoc exclusion of one intervention group. Unclear reporting of outcomes in
terms of assessing effect size and varians.
The study appears to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
High risk
Other bias
Low risk
Holve 1983
Methods
Participants
Interventions
RCT
31 male NB; FT, < 7 days age, > 2500 gm, 5 min Apgar > 7
0.8 ml 1% lidocaine DPNB (n=15)
0.8 ml saline DPNB (n=8)
no treatment control (n=8)
4-5 min WT
HR; % time crying per interval; clinical observation of anesthesia effectiveness (good, fair, poor)
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
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Omskæring - PICO 2 Anæstesi
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
Low risk
Support for judgement
18-Dec-2019
controlled, double-blind investigation wasSubjects were assigned to one of three groups by
use of a random numbers table.
No information on allocation concealment
Operations were performed in a relatively isolated area of the newborn nursery. A single
physician did all circumcisions using a Gomco bell and clamp. Two researchers were present
at each procedure and were blind as to which subjects had DPNB with lidocaine versus saline,
but they were aware of which infants did not receive any injection. All other researchers
remained completely blind to infant group assignment until the end of the study.
The two researchers who were present at each cir- cumcision observed infant response to
operative pro- cedures and together categorized each newborn as having &dquo;good&dquo;
(minimal to no crying or signs of dis- tress), &dquo;fair&dquo; (slightly more agitation), or
&dquo;poor&dquo; an- esthetic effect (significant agitation and distress). Heart rate and crying
data were analyzed by a member of the research team who was not present at the circum-
cisions and who was blind to infant group assignment.
Follow-up data at 1 to 2 months of age were obtained on 23 of the 31 subjects. Eight subjects
were not brought back for follow-up appointments and could not be reached by telephone.All
infants randomized in this study are included in this report.COMMENTSNo analysis done to
evaluate the impact of the failure to analyse the participants in the group they were allocated.
Not reffering to a protocol but report on relevant outcoms
seems free of other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Howard 1994
Methods
Participants
Interventions
RCT
44 male NB, healthy, AGA, FT, Apgars > 7, >/= 24 h age
acetaminophen 15 mg/kg/dose (n= 23)
placebo (n= 21)
given 2 hr prior and q 6H X 24 hr following
Infants were brought to a quiet room near the nursery. They were placed on the Circumstraint (Olympic Medical Co,
Seattle, Wash) board, and their legs were restrained. A nurse held the infants arms in flexion on the chest, and all infants
were offered pacifiers. Infants were allowed to settle for up to 5 minutes before data collection was begun.
HR; RR; cry time; post-operative comfort score; feeding behavior pre/post
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
Low risk
Support for judgement
Using a computer-generated random number list, neonates were randomized to either an
acetaminophen or placebo group.
Not described
All nurses and physicians involved in the study were blinded to the group assignments.
All nurses and physicians involved in the study were blinded to the group assignments.
Two of the authors (C.R.H. and F.M.H.), both blinded to in- fants circumcision status,
performed a pilot test of the Postopera- tive Comfort Score in a group of 55 well, full-term
newborns, 15 of whom were postcircumcision. lntraobserver reliability for this in- strument was
r = .90, and interobserver reliability was r = .85. A comfort score of <16 from <1 hour to 70
hours postcircumcision identified neonates who had undergone circumcision with a posi- tive
predictive value of 85%, a sensitivity of 73%, and specificity of 96%. In the subgroup of
circumcised neonates, a score of <16 predicted with 85% sensitivity and 100% specificity
those neonates who were <24 hours postcircumcision. Interobserver reliability was reverified (r
> .90) in the later half of the current study in a subgroup of 13 neonates.</b> Feeding behavior
was evaluated before
Drop outs not reported
Not reffering to a protocol, but report on relevant outcomes
The study seems to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Howard 1999
Methods
Participants
RCT
62 male NB; healthy; AGA; FT
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Omskæring - PICO 2 Anæstesi
Interventions
1g LP cream + 0.8 ml saline DPNB (n=31)
0.8 ml 1% lidocaine DPNB + 1g placebo cream (n=31)
4 min WT for DPNB
creams applied 1 hr prior and covered with occlusive dressing
HR; RR; behavioral distress score
18-Dec-2019
Outcomes
Notes
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
Parental informed consent was obtained. <b>Infants were randomized in a double-blind
fashion to 1 of 2 study groups according to a random number list maintained in the hospital
pharmacy. A total of 62 in- fants were randomized
Pharmacy personnel responsible for randomization and the application and dispensing of
medications had no other responsibilities in this study. The list was maintained in the hospital
pharmacy
One hour before the procedure and in accord with study group assignment, a pharmacy
research nurse ap- plied 1 g of either a placebo or EMLA cream to the distal half of the infant s
penis. 19 The cream was then covered with an occlusive dressing. The placebo cream was
se- lected to resemble EMLA cream as nearly as possible. Prefilled tuberculin syringes
containing either sodium chloride solution or 1% lidocaine without epinephrine. Personnel
performing the surgery were blinded. Both groups had DPNB and the surringes were masked.
A single observer (C.tH.), blinded to study group assignment and trained in Brazelton
behavioral state assessment, reviewed each tape and assigned dis- tress scores. Behavioural
distress was assessed by a blinded observer. It is not clear who assessed the heart rate or
respiratory rate.
A total of 62 in- fants were randomized; however, only 60 infants com- pleted the protocol.
Before the procedure, tachypnea de- veloped in 1 infant and another infant s parents withdrew
permission for study participation. 60 infants completed the protocol.
Not reffering to a protocol
The study seems to be free from other sources of bias.
Allocation concealment (selection bias)
Low risk
Blinding of participants and personnel
(performance bias)
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Joyce 2001
Methods
Participants
Interventions
RCT
23 male NB, FT; 5 min Apgar > 7; BW > 2500 g; age < 7 d
LP cream (1 - 2 g) + music (n=6)
LP cream + no music (n=5)
placebo cream + music (n=7)
placebo cream + no music (n=5)
cream applied 1 hr prior and covered with occlusive dressing
music started just prior to procedure and continued to 10 min post procedure
HR, O2sat, cry duration; RR, Riley Infant pain scale, salivary cortisol, infant state
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
The randomized, researcher-blinded study was conducted in the newborn nursery of a large
Midwest city hospi- tal.Twenty-three male neonates were ran- domly assigned to the study
groups us- ing a random numbers table.
No information on allocation concealment
Acid Mantle cream, (Doak Dermatologies, Bradley Pharma- ceuticals, Inc, Fairfield, NJ), which
is similar in appearance to EMLA but is inert with no active properties, was used as the
placebo cream. To control for variability in the dose of EMLA, both the EMLA and placebo
creams were drawn into syringes prior to ap- plication. Nurses were instructed to apply the
entire contents of the syringe using a standard protocol. The syringes were labeled A and B,
and data collec- tors did not know which was EMLA and which was placebo cream. Likely
participants and personnel were blinded.
To allow for blinded ratings of pain intensity, the procedure was recorded on videotape with
the following pre- cautions taken to ensure blinded con- ditions: (a) a placebo cream similar to
EMLA in appearance was applied to the penis for the control conditions; (b) observational data
were obtained from the videotapes by research assistants who were not present during the
pro- cedure and who were blinded to the type of cream applied; and (c) blank compact discs
were played for neo- nates in control conditions, allowing for the same sequencing of activities
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Low risk
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
to provide the appearance of audio stim- ulation for all neonates.
the syringes were labeled A and B, and data collec- tors did not know which was EMLA and
which was placebo cream." Likely the outcome assessors were blinded. Pain subjective
assessed and HR and OS objectively assessed
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Unclear risk
No information
Not reffering to a protocol.
No reasons to suspect other sources of bias
Karasu 2018
Methods
Participants
Interventions
Outcomes
Notes
RCT
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
Kass 2001
Methods
Participants
Interventions
RCT
71 healthy male NB
lidocaine DPNB (n=24)
2ml D50W orally (n=23)
2 ml H2O orally (n=24)
WT 2 to 6 min
time cry (primary outcome); HR; O2sat ; modified behavioral pain scale
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
The infants were randomized (by computer modeling) to 1 of the 3 arms of the study. Despite
baseline imbalances in time since last fed and heart rate the randomization was likely
successfully performed.
No information about allocation concealment before the procedures.
The base of the penis in all patients was covered with a sterile 2 × 2 gauze pad secured with
tape to obscure evidence of a DPNB.
The base of the penis in all patients was covered with a sterile 2 × 2 gauze pad secured with
tape to obscure evidence of a DPNB. Likely blinded outcome assessors.
No information about attrition. Likely no missing outcome data.
No protocol however, primary and secondary outcomes clearly stated and similar reported.
No reasons to suspect other sources of bias.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
High risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Kaufman 2002
Methods
Participants
Interventions
RCT
57 NB; healthy; male; FT; Apgar > 7 at 5 min
Mogen + water pacifier (15)
Mogen + 24% sucrose pacifier (n=14)
Gomco+ water pacifier (n=14)
Gomco + 24% sucrose pacifier (n=14)
time crying; grimacing, procedure length
Notes
Outcomes
Review Manager 5.3
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Omskæring - PICO 2 Anæstesi
Notes
18-Dec-2019
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants
undergoing painful procedures. Cochrane Database of Systematic Reviews 2016, Issue 7. Art. No.: CD001069. DOI:
10.1002/14651858.CD001069.pub5.
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Allocation concealment (selection bias)
Low risk
Blinding of participants and personnel
(performance bias)
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Unclear risk
Other bias
Low risk
KazakBengisun 2012
Methods
Participants
RCT
Cadual block (n=30), age 6yr (SD:3), weight 23kg (SD:9), duration of surgery 26min (SD:9), duration of anesthesia 52min
(SD:10)
DPNB (n=30), age 7yr (SD:2), weight 26kg (SD:6), duration of surgery 33min (SD:2), duration of anesthesia 58min (SD:13)
Caudal block: All caudal blocks were performed by one experienced anesthetist in left lateral decubitus position with a 22
G i.v. cannula and 1 mg.kg-1 of 0.25% levobupivacaine was administered from the sacral hiatus.
DPNB: DPNB was applied in the supine position. All penile blocks were performed by one experienced urologist. For the
penile block, 1 mg.kg-1 0.25% levobupivacaine was administered through a 21-G needle.
Demographic data (age, weight, duration of surgery and duration of anesthesia), the number of patients who were pain
free for the first 6 hours, duration of analgesia, the time to first analgesic administration, the rescue analgesic
(paracetamol) demands in 24 hours, motor blocks, the time to first walking and micturition, length of stay were followed,
postoperatively. According to modified Bromage scale,motor weakness was assessed as 0=able to stand or strong leg
movement, 1=able to move legs but unable to stand, 2=no leg movement. Postoperative pain and sedation scores were
assessed on the 10th, 30th minutes, and 1-6 hours, by nurses and parents. Pain was evaluated by Faces Pain Rating
Scale (FPRS), Observer Pain Score (OPS) and Modified Pediatric Objective Pain Scale (MPOPS). OPS and MPOPS
include 5 criteria such as crying, movements, agitation, systolic blood pressure and complains of pain. Nevertheless;
sedation (time to waking) was defined as the time between the end of surgery (E0) and waking. It was assessed by the
Modified Aldrete-Kroulik Recovery Scores that consists of motor activity, respiration, circulation, consciousness and O2
saturation
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
SUPPORTING ANNOTATIONS: "in this single centre, prospective, <b>randomized,
controlled, blind study.</b> Age, weight, surgery and anesthesiathere was no difference in
respect to demographic data (age, weight, duration of surgery and duration of anesthesia)"
"Randomization was done by computer generated random number sequence."
COMMENTS: Unclear how sequence generation was performed
SUPPORTING ANNOTATIONS: "The allocation was concealed in a sealed envelope until the
child was anesthetized"
SUPPORTING ANNOTATIONS: "small spot dressings were applied to the sites of both caudal
and penile injection to avoid observer bias postoperatively.</b> During surgery, a block was."
"This was a blind study: patients, nurses and parents were blinded to the type of given block."
COMMENTS: Likely personnel and participants were blinded.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Low risk
Low risk
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Omskæring - PICO 2 Anæstesi
Blinding of outcome assessment (detection bias) Low risk
18-Dec-2019
SUPPORTING ANNOTATIONS: "Postoperative pain and sedation scores were assessed on
the 10th, 30th minutes, and 1-6 hours, by nurses and parents.Twenty-four hours later, the
parents of the children were called by a member of anesthetic team who was unaware of the
kinds of blocks. The par- ents were asked for their records.This was a blind study: patients,
nurses and parents were blinded to the type of given block. "
COMMENTS: Likely the outcome assessors were blinded
SUPPORTING ANNOTATIONS: "None of the patients was withdrawn from the study with any
reason"
COMMENTS: Not reffering to a protocol but report on relevant outcomes
COMMENTS: The study seems free of other sources of bias
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Kurtis 1999 A
Methods
Participants
Interventions
RCT
48 male NB; FT; 5 min Apgar >/= 7
Mogen clamp and 0.8 ml 1% lidocaine DPNB (n=16)
Mogen clamp and no DPNB (n=16)
Gomco clamp and 0.8 mL 1% lidocaine DPNB (n=8)
Gomco clamp and no DPNB (n=8)
5 minute WT
time crying, HR, O2sat, salivary cortisol, RR
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Unclear risk
Unclear risk
Low risk
Support for judgement
Insuffient information on sequence generation
Insuffient information on allocation concealment
Unblinded, but this is unlikely to influence reporting of outcome. the physicians performing the
circumcisions were not blinded to the anesthesia status.
Unblinded, but this is unlikely to influence reporting of outcome
Insufficient information on incomplete outcome data
No reference to study protocol, but appears to report on all outcomes of interest
The study appears to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Kurtis 1999 B
Methods
Participants
Interventions
RCT
48 male NB; FT; 5 min Apgar >/= 7
Mogen clamp and 0.8 ml 1% lidocaine DPNB (n=16)
Mogen clamp and no DPNB (n=16)
Gomco clamp and 0.8 mL 1% lidocaine DPNB (n=8)
Gomco clamp and no DPNB (n=8)
5 minute WT
Time crying, HR, O2sat, salivary cortisol, RR
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
SUPPORTING ANNOTATIONS: "Infants enrolled were randomized into one of the four
anesthesia/clamp groups."
COMMENTS: Insufficient information on sequence generation
COMMENTS: Insufficient information on allocation concealment
SUPPORTING ANNOTATIONS: "The physicians performing the circumcisions were not
blinded to the anesthesia status."
COMMENTS: Unblinded, but this is unlikely to influence reporting of outcome
COMMENTS: Unblinded, but this is unlikely to influence reporting of outcome
COMMENTS: Insufficient information on incomplete outcome data
COMMENTS: No reference to study protocol, but appears to report on all outcomes of interest
COMMENTS: The study appears to be free from other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
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Lander 1997
Methods
Participants
Interventions
RCT
54 male NB; FT; AGA; 1-3 d age
2g LP cream (n=15)
placebo cream (n=12)
0.8 ml 1% lidocaine DPNB (n=14)
0.8 ml 1% lidocaine RB (n=13)
- penile blocks 8 min WT; creams applied 90 min prior and covered with occlusive dressing
HR; time cry; O2 sat, RR, palmar sweat, metHgb level
18-Dec-2019
Outcomes
Notes
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance
bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement Support for judgement
Unclear risk
Unclear risk
Low risk
Low risk
Low risk
Low risk
Low risk
No information about sequence generation procedure
No information about allocation concealment procedure
Likely personnel were blinded. Type of topical were blinded for all personnel.
Type of topical were blinded for all personnel. Outcome assessors were likely
blinded.
Two infants were withdrawn due to reasons unrelated to study procedure.
No protocol registered. Apparently comprehensive outcome reporting.
No other sources of bias is suspected
Lehr 2005
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
39.2 (0.9) gestational age
Duration of surgery:
Anesthesia duration:
Intervention 2
Age:
39.1 (1.3)
Duration of surgery:
Anesthesia duration:
Control 1
Age:
39.1 (1.2)
Duration of surgery:
Anesthesia duration:
Control 2
Age:
Duration of surgery:
Anesthesia duration:
Overall
Age:
Duration of surgery:
Anesthesia duration:
Included criteria:
Healthy, term males (n = 54), younger than 1 week old undergoing circumcision.
Excluded criteria:
Pretreatment:
Infants in the LMX group were heavier and longer than infants in the to other groups.
Interventions
Intervention Characteristics
Intervention 1
Description:
lidocaine 4% cream (LMX4)
Dose:
4%
Follow-up time:
72 hour
Intervention 2
Description:
lidocaine 2.5% and prilocaine 2.5% (EMLA)
Dose:
lidocaine 2.5% and prilocaine 2.5%
Follow-up time:
72 hour
Control 1
Description:
DPNB
Dose:
Follow-up time:
72 hour
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Omskæring - PICO 2 Anæstesi
Control 2
Description:
Dose:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
18-Dec-2019
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
Unclear risk
Support for judgement
Judgement Comment: Extern service conducted a computer-generated block randomization
Judgement Comment: No information
Judgement Comment: The study states they used open label AND as a consequence all study
personnel were blinded. This is conflicting information.
Judgement Comment: Unlikely the study nurses or the parents evaluating AE were blinded.
Not feasible to blind, but is unlikely to influence reported outcomes
Judgement Comment: AE data is reported for all groups. few dropouts in each group
Judgement Comment: No pre-specified protocol. No reasons to expect selective outcome
reporting bias.
Judgement Comment: No reasons to expect other sources of bias.
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Lunn 1979
Methods
Participants
RCT
40 boys aged 2-12 years selected for day-case circumcision for surgical reasons.
Exclusion criteria: unfused sacral vertebrae.
Setting: UK
CAUDAL versus PARENTERAL
Caudal (n = 20): 0.5% bupivacaine, 1.5 mg/kg. Patient semi-prone - no other technique details described.
Parenteral analgesia (n = 20): IM morphine 0.15 mg/kg administered leL deltoid as surgery started.
10-cm linear analogue scale labelled asleep at one end and restless at the other were marked by independent
experienced staI nurse every 5 minutes for 30 minutes.
Need for rescue analgesia (in recovery room)
Incidence of vomiting (in recovery room)
Incidence of later vomiting - partial results only (not able to be used)
Duration of stay in day unit
Time to standing unaided
Complications assessed by community nurse in first 24 hours and at Surgical Outpatients at one week.
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Unclear risk
Low risk
Support for judgement
Random numbers were used to allocate patients into two groups.
No information on allocation concealment
No member of staff in the recovery room knew which technique of analgesia had been
used.All the patients were treated in the same manner by the same anaesthetist.Those who
were to receive intra- muscular morphine did so as surgery started: 0.15 mg/kg was given into
the left deltoid muscle. Those who were to receive caudal analgesia were turned into the
semi-prone position and received 1.5 mg/kg bupivacaine (0.5% without adrenaline). As soon
as the injection was completed, a dressing was applied and the child was taken into theatre.
Likely the parent and surgeon were blinded.
Observations about later recovery at home were recorded by the Community Nurse who
visited the patients twice in the next 24 hr. Final healing and overall results were noted at the
subsequent visit to Surgical Outpatients one week later. Some months later measurement of
the length of the analogue line were made by the author before the nature of the analgesia
was again known.An independent experienced staff nurse made special notes of the child s
behaviour.COMMENTSUnclear if the nurses were blinded. Likely the author were blinded.
Not all the records about vomiting were complete. Three out of 13 boys who received caudals
(23%) and 8 out of 12 (80%) who received morphine, vomited (,yz 7.26: P
<0.01).COMMENTSNo information about attrition. Likely all participants were included in
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Unclear risk
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Omskæring - PICO 2 Anæstesi
follow up and hence in analysis.
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Not reffering to a protocol but report on relevant outcomes
18-Dec-2019
Only one author/investigator who also assessed outcome and performed analysis.
Macke 2001
Methods
Participants
Interventions
RCT
60 male NB; FT; Apgar >/= 8
acetaminophen 10 mg/kg (n=29)
placebo (n=31)
given 1 hr prior to circumcision
HR , Nursing Child Assessment Feeding Scale, cry time, infant state
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
Groups were compared, and no significant differences were found (see Table 1). Most
mothers in the study were white: 93% in the analgesia group and 90% in the placebo group.
Groups also were compared on variables related to the circumcision; no significant differences
were found except for type of physicianA pretest-posttest experimental design with random-
ized group assignment was used. The pharmacy staff determined group
assignments.COMMENTSUnclear sequence generation
No information on allocation concealment
Physicians, mothers, nurses, and the investigator were blind to participant groups. Participants
were recruited at the convenience of the investigator, who explained the study and obtained
consent.
The investigator conducted all the observations to ensure uniform routine care for the
newborns.The investigator analyzed the taped crying, and to ensure reliability, after every 20
newborn cry tapes, another investigator analyzed the tape.The investigator, certi- fied in the
use of the NCAST tools, observed all the feeding interactions.COMMENTSUnclear how the
investigator/assessor remained blinded.
No information about attrition. Likely no missin data.
Not reffering to a protocol but report on relevant outcome.
The main (only) author is also the primary investigator.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Mak 2001
Methods
Participants
Interventions
RCT
187 (185) boys aged between 1 and 12 years, admitted for elective day-surgery circumcision.
Setting: Hong Kong
CAUDAL versus DNPB versus RECTAL/IV
Caudal (n = 61 (63)): 0.25% bupivacaine 0.5 ml/kg, maximum 20 ml - following induction, caudal blocks
were given aseptically to the boys lying in a leL lateral position.
DNPB (n = 63): 0.5% bupivacaine, < 15 kg - 2ml, 15-24 kg - 2.5 ml, 25-30 kg - 3 ml, 31-40 kg - 3.5 ml, > 40
kg - 4 ml; via intrapubic approach as described by Yeoman.
RD/IVFENT (n = 61): Rectal diclofenac (1 mg/kg) and intravenous fentanyl 0.5 g/kg.
Anaesthesia was induced by inhalation of sevoflurane and oxygen or intravenous propofol; maintained
with nitrous oxide in oxygen and isoflurane.
Rescue analgesia (failed block)
Other analgesia (no analgesia was given in the recovery ward, nurses gave oral paracetamol in day
surgery ward if the boys complained of moderate or severe pain, or cried even in their parents' presence,
or thrashed in beds, or were refrained from movement)
Duration of analgesia
Bleeding
Haematoma/bruising of needle site
Vomiting
Hospital stay
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Outcomes
Notes
Risk of bias table
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Omskæring - PICO 2 Anæstesi
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
18-Dec-2019
SUPPORTING ANNOTATIONS: "There were no significant differences found among the three
groups in terms of age and weight.Post-circumcision analgesia in children 147 <b>allocated
randomly to one of three groups by drawing cards.</b> Informed parental consents were
obtained."
Comments: No information on allocation concealment
SUPPORTING ANNOTATIONS: "Anaesthesia was induced by inhalation of sevoflu- rane and
oxygen or intravenous propofol. Following inductions, caudal blocks were given aseptically to
patients lying in a left lateral position and dorsal penile nerve blocks were given via an
infrapubic approach as described by Yeoman et al. 5 All caudal blocks were given by the
Hong Kong Buddhist Hospital s special- ist anaesthetist. Intravenous fentanyl was adminis-
tered by anaesthetists while rectal diclofenac was administered by nursing staff."
COMMENTS: No information about blinding of the personnel performing the procedure. The
parents were likely blinded
SUPPORTING ANNOTATIONS: "Just before discharge, a medical staff member inspected the
patient for wound bleeding and, for those boys who had received caudal block, instructed
parents to remove the sacral dressings the following morning." "After returning to the day
surgery ward, nursing staff, who were unaware of the type of analgesia given, started to record
the pain response with respect to verbal complaints (mild, moderate or severe pain), crying
and signs of distress. Thereafter, the boys were assessed at hourly intervals or earlier if
complaints from the boys or parents arose between intervals." "Parents were allowed to come
into the recovery ward to alleviate their child s fear. After returning to the day surgery ward,
nursing staff, who were unaware of the type of analgesia given, started to record the pain
response with respect to verbal complaints (mild, moderate or severe pain), crying and signs
of distress. Thereafter, the boys were assessed at hourly intervals or earlier if complaints from
the boys or parents arose between intervals."
Comments: Nurses but not the patients were blinded.
SUPPORTING ANNOTATIONS: "Two boys had caudal blocks abandoned because of
technical difficulties and these two boys were excluded from the study"
COMMENTS: No protocol and no reporting of the pain responses assessed - stated in the
methods section
COMMENTS: No reasons to suspect other sources of bias.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Unclear risk
Low risk
Marchette 1989
Methods
Participants
Interventions
RCT
103 male NB; Apgar >/= 8
classical music (n=25)
intrauterine sounds (n=15)
control (no nurse present) (n=18)
HR; heart rhythm; BP; TcpO2; MDFMCS; BNAS
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
Marchette 1991
Methods
Participants
Interventions
RCT
121 male NB; Apgar =/> 6; normal delivery; 2 - 9 days age
taped music (n=20)
intrauterine sounds (n=20)
pacifier (n=20)
music and pacifier (n=20)
intrauterine sounds and pacifier (n=20)
control - no treatment (n=21)
HR, rhythm, BP; tcPO2; rate pressure product, BNAS; crying
Outcomes
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Notes
18-Dec-2019
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
Martin 1982
Methods
Participants
RCT
60 inpatient boys admitted consecutively to hospital for circumcision. No age range given but mean
age 5.6-6.5 in the three groups.
Exclusion criteria: none reported.
Setting: UK
CAUDAL (CAUDAL or CAUDAL+OPIOID) versus PARENTERAL OPIOID
Caudal: 0.5% bupivacaine, 0.5 ml/kg (n=20).
Caudal: 0.5% bupivacaine and morphine 0.2 mg/ml, 0.5 ml/kg (n=20).
Diamorphine 0.07 mg/kg, 0.05 mg/kg given IV during early part of operation and 0.02 mg/kg given IM
when surgery completed (n = 20).
Pain: No criteria for rescue analgesia although paracetamol elixir said to be given by mouth if required.
However diamorphine was given in the ward for two patients in the bupivacaine only caudal group due
to block failures. 10-cm linear analogue scale of "anaesthetised child" at one end and "screaming and
uncontrollable" at the other. Completed every 5 minutes for 1st hour, every 15 minutes for second hour
then hourly for 4 more hours. Assessed by paediatric ward sister and a small number of staI nurses under
her supervision.
Number of patients vomiting.
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
The characteristics of the three groups are shown in table I and it will be seen that they are
comparable.Sixty boys admitted consecutively to hospital from the waiting list for circumcision
were randomly allocated to one of three groups.COMMENTSLikely random allocation however
unclear sequence generation.
No information on allocation concealment
No information on blinding
After the operation children were assessed on a linear analogue scale by the paediatric ward
sister and a small number of staff nurses under her super- vision.COMMENTSNo information
about blinding of the ward sister or the staff nurses.
The results were different in the group receiving the caudal injection with bupivacaine alone.
There were two complete failures in this group and diamorphine had to be given in the ward
because of distress. One was a technical failure occasioned by anatomical abnormality and
the other occurred in a small child in whom there was emotional distur-
bance.COMMENTSTwo patients were excluded from the caudal injection with bupivacaine
alone group. Per protocol analysis.
No protocol however, thorough reporting of stated outcome pain/behaviour.
No reasons to suspect other sources of bias.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Low risk
Unclear risk
Masciello 1990
Methods
Participants
Interventions
RCT
30 male NB, healthy, FT
0.8 ml 1% lidocaine DPNB (n=10)
0.8 ml 1% lidocaine local block (n=10)
no treatment control (n=10)
5 min WT
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Omskæring - PICO 2 Anæstesi
Outcomes
Notes
plasma cortisol, HR, O2sat, cry
18-Dec-2019
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Unclear risk
Unclear risk
High risk
Support for judgement
Unclear how sequence generation were performed
No information on allocation concealment
Personnel not blinded. - All anesthetic procedures and circumcisions were performed in an
identical manner by the principal investigator.
Not described
One infant from each group were excluded from analysis on cortisol levels because of
improper handling.
No protocol. However, all relevant outcomes seem to be reported. Report on relevant outcomes
The study seems free of other bias
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Unclear risk
Low risk
Maxwell 1987
Methods
Participants
Interventions
RCT
30 male NB; FT; healthy
0.8 ml 1% lidocaine DPNB (n=20)
no treatment control (n=10)
5 min WT
HR, O2sat, BP, plasma lidocaine
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance
bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement Support for judgement
Low risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Low risk
Low risk
Randomization by drawing cards. No baseline imbalances between groups
No information about allocation concealment
Surgeon was blinded to the procedure. No information about blinding of other
personnel.
No information about blinding of outcome assessors.
No information about missing data nor drop outs. 4 children had insufficient blocks
No protocol however, all outcomes were relevant and thorough reported.
No reasons to suspect other sources of bias.
May 1982
Methods
Participants
Interventions
RCT
44 healthy boys aged 9 months to 9 years, presenting for circumcision as day cases.
Setting: UK
CAUDAL versus PARENTERAL
Caudal (n = 21): 0.25% bupivacaine, 0.5 ml/kg.
Control (n = 23): buprenorphine 3 ug/kg IM.
postop.
3 further assessments by parents over next 24 hours with results via returned questionnaire. No record
of how many questionnaires returned.
Need for additional analgesia (aspirin) both in and out of hospital noted.
Complications: not formally studied.
Nausea and vomiting: noted in recovery and by returned questionnaire.
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
SUPPORTING ANNOTATIONS: "Random numbers were used to allocate the patients into
two groups."
COMMENTS: Random numbers
COMMENTS: No information on allocation concealment
Allocation concealment (selection bias)
Unclear risk
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Omskæring - PICO 2 Anæstesi
Blinding of participants and personnel
(performance bias)
Unclear risk
18-Dec-2019
SUPPORTING ANNOTATIONS: "Both groups had Elastoplast dressings placed over the
lateral aspect of the thigh and also over the sacral hiatus so that the injection site was not
visible to the person making the postoperative assessment." COMMENTS: Blinding of
personnel is not described. It is unclear whether the operating surgeon was aware of the type
of anasthesia given.
SUPPORTING ANNOTATIONS: aspirin (10 mg/kg) orally. All <b>the observations were made
by one of the authors (A.M), who was unaware of the analgesic techniques used. Further
assessments were made by the child s parents" "Both groups had Elastoplast dressings
placed over the lateral aspect of the thigh and also over the sacral hiatus so that the injection
site was not visible to the person making the postoperative assessment."
COMMENTS: Outcome assessor blinded
COMMENTS: It seems there is no drop out
COMMENTS: No protocol available. The study has not included heart rate or oxygen saturation
COMMENTS: The study seems to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Mohan 1998
Methods
Participants
Interventions
RCT
60 male NB; FT; BW>/= 2500 g; 5 min Apgar >/= 7; < 5 days age
5 g LP cream + 2 ml 24% sucrose via pacifier (n=19)
5 g LP cream + water via pacifier (n=20)
2 ml 24% sucrose via pacifier (n=21)
water via pacifier (n=19) - non-randomized control
cream applied 45-60 min prior, covered with occlusive dressing
HR; O2sat; BP; cry duration
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance
bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors'
judgement
Unclear risk
Unclear risk
Low risk
Unclear risk
Low risk
Low risk
Unclear risk
Support for judgement
Not clear how participants were randomly assigned
No information on allocation concealment
The person performing the procedure was blinded as to the analgesic agent or agents
used.
unclear if outcome assessors were blinded
One infant from the control group was eliminated.
No protocol. However, all relevant outcomes seem to be included.
The control group was not randomly assigned.
Mudge 1989
Methods
Participants
Interventions
RCT
44 male NB; 5 min Apgar > 7; BW 2.5 - 4.5 kg; FT; age 12 - 72 h
4% lidocaine cream (n=20)
placebo cream (n=24)
cream applied 2 hr prior covered with occlusive dressing
HR, RR, O2sat, cry time, behavior
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
SUPPORTING ANNOTATIONS: "The groups were compared as to the variables of weight,
Apgar scores, blood pressure, gestational age, chronological age, and time since eating.
T-tests were performed to test differences, and no differences were found."
COMMENTS: Unclear how the random sequence was generated but no differences at
baseline.
SUPPORTING ANNOTATIONS: "The pharmacist kept the randomized list, and it was not
given to the investigator until after the study. "
COMMENTS: Likely the allocation was concealed
SUPPORTING ANNOTATIONSThis was done by the institutional pharmacist, who prepared
packets of either 4% lido- Caine mixed with acid mantle or acid mantle cream only.The cream
was covered with an occlusive dressing of Saran wrap and secured with tape."
Allocation concealment (selection bias)
Low risk
Blinding of participants and personnel
(performance bias)
Unclear risk
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Blinding of outcome assessment (detection bias) Unclear risk
18-Dec-2019
COMMENTS: Unclear if the personnel were blinded throughout the procedure.
SUPPORTING ANNOTATIONS: "Throughout the procedure, the investigator and the
physician carefully observed the infant s reaction to the circumcision." "the severity of the
overt response of the infant was dichotomously cate- gorized as distressed or not distressed,
by joint agreement of the in- vestigator and the physician." "The pharmacist kept the
randomized list, and it was not given to the investigator until after the study."
COMMENTS: Likely the investigator were blinded. Unclear if the physician were blinded.
COMMENTS: Seems that all children are included in analysis.
COMMENTS: Not reffering to a protocol but report on relevant outcomes No protocol. Clearly
stated purposes, hypothesis and outcomes to measure. Reporting lacking variance.
COMMENTS: The study seems free of other bias
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Mujeep 2013
Methods
Participants
Interventions
RCT
Age: 2 months (range: 1-6 months)
EMLA (n=50): "1-2 gm of EMLA cream was applied over the glans and prepuce. An occlusive Opsite (Smith & Nephew, Inc
USA) dressing was applied, one hour prior to the procedure. "
DPNB (n=50): "injection was given by infiltrating 1ml of 1% (plain) lignocaine at penile base."
HR, RR, and oxygen saturation. Neonatal infant Pain Scale (NIPS).
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
here was no statistically significant difference in base line parameters in both the groups
except for the respiratory rate, which was significantly raised in DPNB group (<.01).Health
Karachi, from May 2008 to October 2008. Patients under six month of age were randomized in
to two groups (EMLA and DPNB) of fifty patients each. The effectiveness of pain control was
assessed by measuring.
For assigning into each group balloting was used on operation day.
COMMENTSLikely sequence generation was random but unclear. No baseline group
differences.
No information on allocation concealment
No information on blnding
Annotation: "An assessor recorded the physiological parameters and pain by using NIPS
score during each standard step of the procedure."
COMMENTS: Unclear if outcome assessors were blinded
No information about attrition.
No protocol. Apparently thorugh outcome reporting.
No other sources of bias suspected
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Naja 2011
Methods
Participants
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
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Newton 1999
Methods
Participants
Interventions
Outcomes
Notes
RCT
194 male NB; healthy
0.8 ml 1% lidocaine DPNB (n=92)
0.8 ml 1% buffered lidocaine (n=102)
HR (primary outcome variable); O2sat; number crying/phase; modified BNAS
18-Dec-2019
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
Panda 2011
Methods
Participants
Interventions
RCT
Sixty children between the age of 1-10 years belonging to American Society of Anesthesiologists (ASA) grades I and II
were enrolled in the present study in a randomized manner and divided equally into two groups of 30 each.
Intervention:
Children in group G underwent a standard general anaesthetic. Induction of anaesthesia was achieved with a gas mixture
of oxygen, nitrous oxide (50:50), sevoflurane (2-4%) and fentanyl 1-2
g/kg
body weight. Oral endotracheal intubation was
performed with appropriately sized polyvinyl chloride (PVC) endotracheal tubes, facilitated by succinylcholine in a dose of
1 mg/kg body weight. Maintenance of anaesthesia was done with oxygen, nitrous oxide (40:60) and sevoflurane (1-1.5%),
and vecuronium bromide 0.1 mg/kg body weight was utilized for neuromuscular blockade. Ventilation was controlled with a
closed circuit system connected to a paediatric anaesthetic ventilator (PENLON AV 900). During peri-operative period, any
increase of heart rate or mean arterial pressure (MAP) >20% of the baseline was managed by 25% of the initial dose of
fentanyl as and when required. At the end of the procedure, the residual neuromuscular block was reversed with
neostigmine 0.05 mg/kg body weight and atropine 0.02 mg/kg body weight and patients were extubated after clinical
assessment and thorough orophanyngeal suction.
Control:
In group B, the penile block was administered by the anaesthesiologist using 0.25% bupivacaine without adrenaline in a
dose of 0.5 mg/kg body weight and it was used as an isolated local block. Taking all antiseptic precautions, a 30 mm 23 G
needle was inserted in the midline after gently pulling down the base of the penis by the index finger and directed below
the symphysis pubis through the Scarpa's fascia and into the sub-pubic space. After a negative aspiration for blood, 25%
of the calculated volume of drug was injected. The needle was withdrawn by 1-2 mm and redirected to 11:00 O clock and
1:00 O clock positions and 25% of the calculated volume of drug was injected on either side of midline to block the two
dorsal nerves. Entry of the needle through the Scarpa's fascia was appreciated as a give . An additional puncture was
made on the raphe line at the borderline between the penis and scrotum and the remaining 25% of the calculated drug
volume was injected to alleviate possible pain arising from the skin innervated by the perineal nerves. All these injections
were made very slowly, taking 100-120 seconds to reduce pain during injection.
Intra-operatively, HR, ECG, NIBP (systolic and diastolic) and SpOwer recorded at 5 minute intervals for the first 60 min and
then at 15 minute intervals till the end of procedure. The presence or absence of tears and sweating was also noted at the
similar intervals.Post operatively, HR, NIBP, SpO2 and pain were assessed and recorded at 15 minutes, 1 hour, 4 hours
and 8 hours. The pain relief or absence was assessed for the children by their mother based on cry, irritability or
restlessness of the child on a smiley faces score which had five faces corresponding to 0, 25, 50, 75 and 100% analgesia.
18 ud af de 30 i hver gruppe blev omskåret
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Low risk
High risk
Support for judgement
Computer generated
Coded envelopes. The randomisation process was carried out by the central station staff.
Personnel could not be blinded
Several outcomes were recorded intra-operatively. It is not stated that the outcome assessors
were blinded. Pain and crying observed by mothers
Two patients were excluded from Group B due to a failed block.
Not reffereing to a protocol, but report on relevant outcomes
Blinding of outcome assessment (detection bias) High risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Low risk
Low risk
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Omskæring - PICO 2 Anæstesi
Other bias
Low risk
The study seem to free from other sources of bias
18-Dec-2019
Sharara Chami 2017
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
38.50 (1.35) wk
Duration of surgey:
5.63 (0.78) min
Anesthesia duration
:
intervention 2
Age:
38.45 (1.14) wk
Duration of surgey:
6.59 (1.13) min
Anesthesia duration
:
kontrol 1
Age:
38.65 (0.98) wk
Duration of surgey:
6.31 (0.94) min
Anesthesia duration
:
kontrol 2
Age:
38.26 (1.6) wk
Duration of surgey:
6.35 (1.24) min
Anesthesia duration
:
Overall
Age:
Duration of surgey:
Anesthesia duration
:
Included criteria:
All healthy, late preterm and term (36-41 weeks' gestation) newborn boys admitted to the normal
nursery at the American University of Beirut Medical Center whose parents requested circumcision were eligible for
recruitment. After an infant s first void and clearance for circumcision by the nursery p
Excluded criteria:
Pretreatment:
Similar in baseline characteristics
Interventions
Intervention Characteristics
Intervention 1
Description:
The control group received the traditional anesthetic that is, topical cream EMLA, whereas the
combination groups received additional anesthetic agents.
Dose:
1 g (eutectic mixture of 2.5% lidocaine and 2.5% prilocaine that is used as a topical anesthetic to diminish pain
from cutaneous procedures)
Duration:
Follow-up time:
intervention 2
Description:
EMLA cream is a eutectic mixture of 2.5 % lidocaine and 2.5% prilocaine that is used as a topical
anesthetic to diminish pain from cutaneous procedures. Sixty minutes before the circumcision, 1 g of EMLA cream
was . Sixty minutes before the circumcision, 1 g of EMLA cream was applied by the nurse to the penis of the newborn
and wrapped with Tegaderm dressing (Johnson & Johnson, Inc, Arlington, TX). The cream and dressing were
removed before the procedure. There is sufficient evidence to support the administration of sucrose, often in
conjunction with additional pharmacologic and nonpharmacologic interventions, for relief of procedural pain.13 It is
the neonate s detection of a sweet substance, not the volume, that produces the analgesic effect. As a result, studies
report that 0.05 to 0.5 mL is an adequate volume of 24% to 25% sucrose or glucose for reducing procedural pain in
neonates.14 For this study, 2 mL of 25% sucrose was administered orally and intermittently via a syringe throughout
the circumcision procedure by an assisting nurse.
Dose:
2 ML of 25% sucrose
Duration:
Follow-up time:
kontrol 1
Description:
The placement of EMLA and the administration of sucrose were the same as described for the EMLA +
sucrose group. DPNB is an anesthetic technique that has been extensively used and evaluated in the management
of pain during circumcision since the late 1970s. The pediatric urologist administered the DPNB (2 mg/kg of 1%
lidocaine without epinephrine) in equal aliquots in milliliters at the 2 and 10 o clock positions at the base of the penis
5 minutes before the cirumcision.
Dose:
2 ML of 25% sucrose +2 mg/kg of 1% lidocaine without epinephrine
Duration:
Follow-up time:
kontrol 2
Description:
The placement of EMLA and the administration of sucrose were the same as described for the EMLA +
sucrose group. RB is an anesthetic technique first described in the 1990s,2,16 which has also been examined for
pain control during circumcision. The pediatric urologist administered the RB (2 mg/kg of 1% lidocaine without
epinephrine) in a band around the penis 5 minutes before the circumcision.
Dose:
2 ML of 25% sucrose +2 mg/kg of 1% lidocaine without epinephrine
Duration:
Follow-up time:
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Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
18-Dec-2019
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
Quote: "the control. Randomization and blinding <b>Randomization by blocks of 6 and 9 was
used. The allocation ratio of intervention to control was 2:1. An independent statistician</b>
not involved in the study"
Judgement Comment: An independent statistician not involved in the study conducted the
random assignment process.
Judgement Comment: The random list was held by the research fellow. It is not clear whether
this list was concealed or if he could foresee the next allocation.
Judgement Comment: The surgeon was aware of group assignment
Quote: "random assignment immediately before circumcision. <b>The nurses scoring each
infants pain after the procedure were blinded to the type of analgesia administered, as</b>
were the 2 pediatricians who"
Judgement Comment: Nurses and pediatricians were blinded to the analgesia used.
Judgement Comment: All randomized children were included in the analysis.
Quote: "American University of Beirut approved <b>the protocol and the trial is registered on
clinicaltrials.gov</b> (identifier NCT02990364). All healthy, late"
Judgement Comment: Protocol at clinicaltrials.gov. All stated outcomes are reported
Judgement Comment: The study seem to be free from other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
High risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Low risk
Low risk
Other bias
Low risk
South 2005
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
39.4 (38.9-40) gestational week
Duration of surgery:
11.75 (11.58-12.12) min
Anesthesia duration:
Intervention 2
Age:
Duration of surgery:
Anesthesia duration:
Control 1
Age:
39.7 (38.6-40.6) gestational week
Duration of surgery:
11.98 (11.33-12.38) min
Anesthesia duration:
Control 2
Age:
Duration of surgery:
Anesthesia duration:
Overall
Age:
Duration of surgery:
Anesthesia duration:
Included criteria:
The inclusion criteria included all term healthy infants delivered via vaginal or cesarean birth, including
operative delivery (ie, forceps/vacuum)
Excluded criteria:
We excluded any infant born lessthan 37 weeks gestation, any comorbid illness (ie, anymajor
congenital anomalies or infectious diseases),babies born with an Apgar score less than 7 at 1 minuteand NICU infants
(except if only for a short observational period of %6 hours). In addition, infants wereexcluded if they received more than
routine neonatalmedications, were breastfed by mothers taking sulfonamides or salicylates, and if the parents declined
informedconsent. Any other contraindications to circumcisionbased on current standards of care were also used toexclude
infants from the study.
Pretreatment:
No differences
Interventions
Intervention Characteristics
Intervention 1
Description:
Finger group. All infants received oral Tylenol and a dorsal penile nerve block (DPNB) before
thecircumcision.
Dose:
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Omskæring - PICO 2 Anæstesi
Follow-up time:
Intervention 2
Description:
Dose:
Follow-up time:
18-Dec-2019
Control 1
Description:
Control. All infants received oral Tylenol and a dorsal penile nerve block (DPNB) before thecircumcision.
Dose:
Follow-up time:
Control 2
Description:
Dose:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Low risk
Low risk
Low risk
Support for judgement
Judgement Comment: Block randomization using STATA
Judgement Comment: Allocation concealed from the physician using concealed envelope.
Judgement Comment: Allocation concealed from the physician using concealed
envelopes.Likely participants/parents were unblinded.
Judgement Comment: Standardized assessment of HR, pain (PIPP) and crying time using
nurses blinded to the nature of the study.
Judgement Comment: No reasons to suspect bias from incomplete outcome data however,
one participant from the control group excluded from analysis without stated explanations
("secondary to missing data").
Judgement Comment: No protocol however no reasons to suspect selective outcome reporting.
Judgement Comment: Seems free of other potential biases
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Spencer 1992
Methods
Participants
Interventions
RCT
75 male NB; BW 2500 - 4500 g; >12 hr age; 5 min Apgar > 6; normal exam
lidocaine DPNB - 5 min WT (n=15)
lidocaine DPNB with 2 min WT (n=15)
1% chloroprocaine DPNB with 3 min WT (n=15)
1% chloroprocaine DPNB with 5 min WT (n=15)
no treatment control (n=15)
cry duration, O2Sat, HR, BNAS
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
Seventy-five neonates born in a private teaching hospital were screened and randomly
assigned to series of five groups.
COMMENTSNo information about sequence generation and no informaton about baseline
imbalances between groups.
No information on allocation concealment
Unclear if personnel was blinded No information about blinding.
ll re- search data were recorded on subject data entry sheets and transferred by one keypunch
operator into an IBM computer using ABSTAT software to determine the descriptive and
inferential statistics.Trained recorders logged highest or lowest heart rate and tissue
oxygenation for six circumcision events: anesthetic infusion, lateral clamping, prob- ing, dorsal
cutting, Gomco bell and platform place- ment, and foreskin cutting. Values were obtained
using a pulse oximeter (Nellcor N-100) attached to each subjects right great toe.
COMMENTSNo information about blinding of outcome assessors.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Unclear risk
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Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
No information about missing data or drop outs.
No protocol. All relevant outcomes where reported.
No reasons to suspect other sources of bias.
18-Dec-2019
Stang 1988 A
Methods
Participants
Interventions
RCT
60 male NB; > 24 hr age; BW > 3000 g; 5 min Apgar > 7; uncomplicated delivery
0.8 ml 1% lidocaine DPNB (n=20)
saline DPNB (n=20)
no treatment control (n=20)
5 min WT
*comparison is DPNB versus no treatment
% time cry, modal behavior state, plasma cortisol
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Unclear risk
Unclear risk
Low risk
Support for judgement
Unclear how the sequence generation was performed
Unclear if the allocation was concealed
Stated: Observer assessing newborns behavioral state was blinded. The physicians and
attendant was blinded.
Stated: Observer assessing newborns behavioral state was blinded. The physicians and
attendant was blinded.
No information on attrition however, no complications ocurred. Likely complete outcome data.
Not reffering to a protocol but report on relevant outcomes
No reasons to suspect other sources of bias.
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Stang 1988 B
Methods
Participants
Interventions
Outcomes
Notes
See Stang 1988 A
See Stang 1988 A
See Stang 1988 A
See Stang 1988 A
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Low risk
Low risk
Low risk
Low risk
Low risk
Support for judgement
See Stang 1988 A
See Stang 1988 A
See Stang 1988 A
See Stang 1988 A
See Stang 1988 A
See Stang 1988 A
See Stang 1988 A
Stang 1997
Methods
Participants
Interventions
RCT
83 male NB, > 20 hr age; BW 3000 - 4000 gm; 5 min Apgar >/= 8; FT
group 1 = 0.8 ml 1%
group 2 = 0.8 ml 1%
group 3 = 0.8 ml 1%
group 4 = 0.8 ml 1%
5 min WT
lidocaine DPNB, padded restraint , water via pacifier (n=20)
lidocaine DPNB, regular restraint, 24% sucrose via pacifier (n=20)
buffered lidocaine DPNB, regular restraint, water via pacifier (n=20)
lidocaine DPNB, regular restraint, water via pacifier (n=20) (control)
Outcomes
Notes
behavioral distress scale, plasma cortisol 30 min post-circ
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants
undergoing painful procedures. Cochrane Database of Systematic Reviews 2016, Issue 7. Art. No.: CD001069. DOI:
10.1002/14651858.CD001069.pub5.
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Omskæring - PICO 2 Anæstesi
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
18-Dec-2019
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Please see Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia
in newborn infants undergoing painful procedures. Cochrane Database of Systematic Reviews
2016, Issue 7. Art. No.: CD001069. DOI: 10.1002/14651858.CD001069.pub5.
Allocation concealment (selection bias)
Unclear risk
Blinding of participants and personnel
(performance bias)
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Unclear risk
Other bias
Low risk
Taddio 1997
Methods
Participants
Interventions
RCT
68 male NB, BW >/= 2500 g; FT; no jaundice or metHgb
1 g (1ml) LP cream (n=38)
1 g (1ml) placebo cream (n=30)
creams covered with occlusive dressing for 60 - 80 min prior
HR, time cry, NFCS, systolic/diastolic BP, metHgb
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
The neonates were randomly assigned to receive lidocaine prilocaine or placebo cream.The
characteristics of the 68 neonates, 38 in the lidocaine prilocaine group and 30 in the placebo
group, were similar.
COMMENTSNo information about sequence generation. No baseline imbalances between
groups.
No infomation on allocation concealment
Circumcisions were performed by one of three study-team pe- diatricians in the nursery
treatment room.
COMMENTSStated double blind study however, unclear how personnel and parents were
blinded.
Assessment of Pain <b>The facial activity of the neonates, which reflects the amount of pain
experienced, was assessed by a research assistant unaware of the treatment assignments
who was trained to use the Neona- tal Facial Coding System reliably (kappa, 0.93; P
0.001).</b> 10-12 The presence or absence.
COMMENTSresearch assistant unaware of allocation Pain assessment were likely blidned.
Stated double blind study however, unclear how other outcome assessors were blinded.
Eight neonates were treated with lidocaine prilocaine cream in an un-only in the safety
analysis. <b>Fifty-nine neonates were included in the ef- ficacy analysis: 29 in the
lidocaine prilocaine group and 30 in the placebo group. One neonate in the li-
docaine prilocaine group was excluded because he was not circumcised on the day the
cream was ap- plied. Fifty-five</b> of the neonates were circumcised.
COMMENTSHigh exclusion from intervention group (n=9), also compared to the control (n=0).
No analysis (ITT) of the impact of not analyzing participants in the group they were allocated.
Not reffering to a protocol but report on relevant outcome
Supported by Astra Pharma Inc., Canada, and by a grant from the Med- ical Research Council
of Canada Pharmaceutical Manufacturers Associa- tion of Canada.COMMENTSNo reasons
to suspect other sources of bias.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
High risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
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Teunkens 2018
Methods
Participants
Interventions
Outcomes
Notes
RCT
18-Dec-2019
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Authors'
judgement
Low risk
Low risk
Support for judgement
patients were ran- domly allocated to one of the 2 study groups receiving either a land- mark
DPNB or an ultrasound DPNB, using a computer-generated random table.
Allocation concealment was ensured by enclosing assignments in sealed, opaque,
sequentially numbered envelopes, which were brought to the operation room by a study nurse
and opened only after the arri- val of the patient in the operating theater by the investigator.
Personnel could not be blinded.
Anesthesiologists and nurses who were at any time responsible for the follow-up of the
study-patients were blinded for the technique used, as were the patients and their
parents.Study outcomes were assessed postoperatively by blinded nurses and
anesthesiologists
Loss to follow up was evenly distributed between the two groups however rather substantial.
Landmark lost 29 and ultrasound 33.
Refer to a protocol. (I was not able to locate it).EUDRACT 2012-001217- 16).
The study seems to be free from other sources of bias
Blinding of participants and personnel
(performance bias)
High risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Tutuncu 2018
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
44.1 ± 23.9 month
Duration of surgey:
Anesthesia duration
:
intervention 2
Age:
Duration of surgey:
Anesthesia duration
:
kontrol 1
Age:
46.2 ± 32.7 month
Duration of surgey:
Anesthesia duration
:
kontrol 2
Age:
Duration of surgey:
Anesthesia duration
:
Overall
Age:
Duration of surgey:
Anesthesia duration
:
Included criteria:
The study enrolled 85 children with ASA (American Society of Anesthesiologist Physical Status) I-II and
in the age range of 1-10 years, planned to undergo cir-cumcision.
Excluded criteria:
Children with neurological or neuromuscular disorders, a history of hemorrhage or coagulation
disorders were not included in the study.
Pretreatment:
There were not signifi-cant differences between groups with respect to age and body weight.
Interventions
Intervention Characteristics
Intervention 1
Description:
In pudendal nerve block group (PDB group ) Pudendal nerve block was performed by same two
anesthesiolo-gists a in the lithotomy position, after the appropriate skin sterilization. The nerve stimulator was
adjusted to 3mA and 2Hz, and the stimulator needle (22-24 G Stimuplex A, 50-100mm, B. Braun, Melsungen,
Ger-many) was inserted from the inferomedial of ischial tuberosities while palpating the tuberosities located at
position of 3 and 9 o clock of the anus (Figure 1). Bu-pivacaine administered as a 0.25 % mixture at 0.3 ml/kg
volume. Injection was performed bilaterally after the perineal muscle contraction and the up-down penile movements.
Dose:
0.3 ml/kg 0.25 % bupivacaine
Duration:
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Follow-up time:
24 hours after operation
18-Dec-2019
intervention 2
Description:
In pudendal nerve block group (PDB group ) Pudendal nerve block was performed by same two
anesthesiolo-gists a in the lithotomy position, after the appropriate skin sterilization. The nerve stimulator was
adjusted to 3mA and 2Hz, and the stimulator needle (22-24 G Stimuplex A, 50-100mm, B. Braun, Melsungen,
Ger-many) was inserted from the inferomedial of ischial tuberosities while palpating the tuberosities located at
position of 3 and 9 o clock of the anus (Figure 1). Bu-pivacaine administered as a 0.25 % mixture at 0.3 ml/kg
volume. Injection was performed bilaterally after the perineal muscle contraction and the up-down penile movements.
Dose:
Duration:
Follow-up time:
kontrol 1
Description:
In penile nerve block group (PNB group), dorsal pe-nile block was achieved by two surgeons in the
supine position, after skin sterilization, by palpating the sym-physis pubis and perforating the Scarpa s fascia with a
pop feeling by 25 G needle and injecting 0.25 % bu-pivacaine mixture of 0.3 ml/kg volume on the midline into the
dorsal base of penis, between the pubis and the penis under Scarpa s fascia
Dose:
0.3 ml/kg bupivacaine was applied with nerve stimulator at a concentration of 0.25 %
Duration:
Follow-up time:
24 hours after operation
kontrol 2
Description:
Dose:
Duration:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
Quote: "The patients randomization was performed with sealed enveloped techniques (based
on computer-generated random numbers), and they were randomly divided into two groups,"
Judgement Comment: computer-generated random numbers
Quote: "sealed enveloped techniques (based"
Judgement Comment: Sealed envelopes
Judgement Comment: Patients are blinded but unclear if personnel are blinded. Surgeons
could not be blinded
Quote: "The families, blind to the type of nerve block performed on the patient, were previously
instructed on the postoperative pain evaluation which was made easy by the selective use of
the Faces Pain"
Quote: "All patients were evaluated in the pediatric recovery room by two different
anesthesiologists who did not know which technique was performed for anal- gesia during the
surgery. The secondary outcome was to evaluate the hemodynamic response of the blocks
during surgery."
Judgement Comment: The postoperative pain evaluation and the analgesic applications were
carried out by the recovery unit anasthetists who were blinded to the type of nerve block
technique. The families later reported pain evaluations. They were also blindedOBS
sekundære outcomes blev assessed under operationen. Her er det ikke beskrevet om det er
af en blinded person.
Judgement Comment: dropout balanced between groups and with same reason. two patients
were loss to follow up from each group. Reason for exclusion were the same in both groups.
Quote: "Clinical trial no: NCT03258255)"
Judgement Comment: Protocol at clinicaltrials. Stated outcomes are reported.
Quote: "Authors declare that they have no conflict of interest."
Judgement Comment: The study seem to be free from other sources of bias
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Low risk
High risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Vater 1985
Methods
Participants
Interventions
RCT
50 boys aged 1-13 years, admitted to day ward.
Setting: UK
CAUDAL versus DNPB
Caudal (n = 25): 0.25% bupivacaine 0.5 ml/kg.
DBPB (n = 25): 0.5% bupivacaine 3 ml (1-5 years) or 4 ml (5-13 years) via 23G needle.
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Omskæring - PICO 2 Anæstesi
Outcomes
Pain: scored on 3-point scale (good, fair, poor) at 2 and 4 hours.
Rescue analgesia administered if pain relief deemed "poor" (required IM morphine sulphate within 1
hour of surgery).
Time to first micturition, standing unaided, and oral fluids requested by child.
After discharge questionnaire at 6,8,and 24 hours regarding pain (verbal rating score) and analgesic
use, vomiting, micturition at home and mobilization.
18-Dec-2019
Notes
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Unclear risk
Unclear risk
Low risk
Support for judgement
SUPPORTING ANNOTATIONS: "allocated randomly"
COMMENTS: unclear how sequence generation was performed
COMMENTS: No information on allocation on allocation concealment
SUPPORTING ANNOTATIONS: "order to permit unbiased assessment, a dressing was
applied to each of the two possible puncture sites in every child."
COMMENTS: It is not described if the operating surgeon was blinded or not.
SUPPORTING ANNOTATIONS: "n order to permit unbiased assessment, a dressing was
applied to each of the two possible puncture sites in every child."
COMMENTS: One anasthetist, ignorant of the local technique employed, performed all
assessments. Parents assessed the child 6 and 8 hours following surgery
COMMENTS: Two patients from the DNB group were excluded and one patient from the
caudal group was excluded. equal distriution of dropout
COMMENTS: No protocol available. The study seems to report on all relevant outcomes,
however, they have not included heart rate or oxygen saturation
COMMENTS: The study seems to be free from other sources of bias
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Wang 2019
Methods
Participants
RCT
110 ASA physical statuses I to II boys, aged 7 to 14 years old with normal cognition.
Caudal block (n=43): age 12.5 (SD: 2.6)
DPNB (n=47): age 11.7 (SD: 2.9)
Caudal block: A caudal block was performed in the patients of Group CB with the lateral position followed by the loss of
consciousness. A single injection of 0.25% ropivacaine (Naropina, AstraZeneca AB, Sweden) plus 0.8% lidocaine
(Lidocaine Hydrochloride Injection, Shanghai Chaohui Pharmaceutical Group, China), a total of 0.5ml/kg, was
administered using a standard anatomical landmark technique.
DPNB: The patients in Group DPNB received dorsal penile nerve blocks via perineal approach, under the direction of a
realtime ultrasonography. A single injection of 0.25% ropivacaine plus 0.8% lidocaine, a total volume of 3-5ml, was given
Continuous noninvasive monitoring items including noninvasive blood pressure (NIBP), electrocardiograph (ECG),
peripheral oxygen saturation (SPO2), and respiratory rate were obtained by the monitors. Postoperative pain score (NRS)
using two pain rating scales by an anesthesia nurse blinded to this trial. Adverse efects such as nausea, vomiting,
numbness of the lower limbs, and other postoperative complications within the 2 days afer the surgeries were also
recorded and compared.
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
SUPPORTING ANNOTATIONS: "The patients were randomly and evenly divided into two
parallel groups, Group DPNB, and Group CB, with the random number generated by the Excel
software (Microsoft Office, 2007 edition). No difference was found in the mean age, weight,
height, and BMI between the two groups (all P values were more than 0.05)."
COMMENTS: No information on allocation concealment
SUPPORTING ANNOTATIONS: "Caudal blocks and dorsal penile nerve blocks were
performed by wellexperienced pediatric anesthesiologists blinded to the study. All
circumcisions were performed using the same surgical technique by senior pediatric surgeons.
All information on surgeries was recorded."
COMMENTS: Unclear if and how parents were blinded
SUPPORTING ANNOTATIONS: "leaving the PACU, all patients were evaluated on the
postoperative pain score using two pain rating scales by an anesthesia nurse blinded to this
trial"
SUPPORTING ANNOTATIONS: "With 14 dropouts, 90 patients were recruited and finally
analyzed, with 47 in Group DPNB and 43 in Group CB (Figure 3). All patients completed
surgeries under general anesthesia with a caudal block or a dorsal penile nerve block."
COMMENTS: Per protocol analysis. No analysis of the impact of the failure to analyze
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
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Omskæring - PICO 2 Anæstesi
particpants in the group they were allocated.
Selective reporting (reporting bias)
High risk
18-Dec-2019
SUPPORTING ANNOTATIONS: "(registration No.: ChiCTR-IPR- 15006670, Principal
investigator: Xiaowei Qian)"
COMMENTS: Protocol available. Primary outcome Body movement during surgery not
reported at all in study. Postoperative pain score (other primary outcome) reported as stated.
Postoperative restlessness, nausea, vomiting, urinary retention, itching and other adverse
reactions (other primary outcome) reported as stated. Respiratory depression during surgery
(secondary outcome) not reported in article. Pulse oximetry not reported either.
SUPPORTING ANNOTATIONS: "This work was supported by grants funded from Zhejiang
Medical and Health Science Technology Program (no. 2017185647) and Wenzhou Public
Welfare Science and Technology Pro- gram (no. Y20160381)."
COMMENTSThe study seems free of other sources of bias
Other bias
Low risk
Weatherstone 1993
Methods
Participants
Interventions
RCT
30 male NB; BW >/= 2500 g; FT; Apgar >/= 7; 6-72 hr age
0.5 g 30% lidocaine cream (n=15)
placebo cream (n=15)
applied 20 min prior to circumcision and covered with occlusive dressing
HR, RR, O2 sat, BP, Newborn Pain Behavior Scale, serum B-endophin (15 min post), serum lidocaine
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
By computer-generated randomization,parental consent was ob- tamed. <b>By
computer-generated randomization, 15 subjects were assigned to receive a topical application
of 30% lidocaine in acid mantle cream (treatment group) 20 minutes prior to circumcision and
15 subjects were assigned to receive the acid mantle cream alone (placebo group).</b> Both
pharmaceutical preparations were compounded.
No information on allocation concealment
the placebo or lidocaine cream (approximately 0.5 g) was applied to the penis using gloved
hands to avoid detection of the anesthetic by the investigator. A small piece of plastic wrap
was then applied over the cream to form an occlusive dressing and the diaper was
secured.</b> The newborn was monitored forCOMMENTSPersonnel were likely blinded.
the newborn was scored for behavioral state, leg movement, arm movement, facial
expression, torso movement, respiratory pattern, soothability re- sponse to distress by
caregivers, and tactile stimulation. The tapes were viewed in 30-second intervals (15 seconds
of observation and 15 seconds of recording scores) by blinded observers.</b> Interobserver
reliabifity of scoring onCOMMENTSLikely outcome assessors were blinded.
twelve subjects in the lidocaine group and 13 in the placebo group had complete analysis of
the video recordingsCOMMENTSNo analysis of the impact of not analysing the patients in the
group they were allocated.
Not reffering to a protocol but report on relevant outcomes
No reasons to suspect other sources of bias.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Weksler 2005
Methods
Participants
Interventions
RCT
100 ASA I and II boys aged 3 to 8 years undergoing circumcision for religious reasons; day surgery.
Setting: hospital in Israel
CAUDAL versus DNPB
Caudal (n = 50): 1 ml/kg body weight of 0.25% bupivacaine (up to 20 ml), in lateral position.
DNBP (n = 50): bupivacaine (0.5% 0.2 ml/kg) injected into the two compartments of the subpubic space,
with an additional ventral infiltration of a small volume of bupivacaine (0.1 ml/kg) along the raphe of
the penis.
Pain (five point face pain assessment - excruciating, severe, moderate, some, no pain) - 10-cm VAS.
Analgesia (15 mg/kg of oral paracetamol given as postoperative pain relief for severe or excruciating
pain).
Rescue analgesia (paracetamol in recovery room).
Any analgesia (assumed that 2 boys who had rescue analgesia (in the caudal group) were different boys
from the 10 who had paracetamol at home).
Induction-incision time (time interval from the beginning of the halothane administration until the beginning
of surgery).
Complications:
haematoma at base of penis
motor block
Outcomes
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tachycardia
phonation
movement
Nausea and vomiting
Time to discharge
Parental satisfaction (10-cm VAS: 0 = not satisfied at all to 10 = extraordinarily satisfied).
Notes
18-Dec-2019
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
SUPPORTING ANNOTATIONS: "One hundred consecutive ASA I and II children aged from 3
to 8 years undergoing circumcision for religious reasons were enrolled in this study and
allocated to two groups of 50 patients each by a lottery of closed envelopes.allocated to two
groups of 50 patients each by a lottery of closed envelopes."
COMMENTS: Lottery of closed envelopes.
SUPPORTING ANNOTATIONS: "study and allocated to two groups of 50 patients each by a
lottery of closed envelopes."
COMMENTS: Closed envelops
COMMENTS: Blinding not feasable and not described.
SUPPORTING ANNOTATIONS: "Immediately after surgery, the children were trans- ferred to
the recovery room where a nurse who was unaware of the study protocol applied the five-point
Faces Pain Assessment Ruler [9] (Fig. 1) when the child was fully awake for pain intensity
self-assessment."
COMMENTS: Parents also reported the need for paracetamol at home (it is not clear if they
were blinded or not).
COMMENTS: Seems that all children are included in analysis
COMMENTS: No protocol available. It seems that the study report on all relevant outcomes
(not heart rate or oxygen saturation)
COMMENTS: The study seems to be free from other sources of bias.
Allocation concealment (selection bias)
Low risk
Blinding of participants and personnel
(performance bias)
Unclear risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
White 1983
Methods
Participants
RCT
50 boys aged 2-12 years undergoing circumcision for medical indications as day patients.
Exclusion criteria: none noted.
Setting: UK
CAUDAL versus DNPB
Caudal (n = 23): 0.5% bupivacaine 0.5 ml/year of age.
DNPB: bupivacaine 0.5% 0.2 ml/kg.
Pain: Need for rescue analgesia assessed by anaesthetist in recovery.
Criteria for rescue analgesia not stated.
Time to first evidence of pain.
Need for paracetamol after discharge, quality of night's sleep (questionnaire returned by patient's family).
Other Outcomes: Incidence of leg weakness and haematoma.
Abstract.
Please see Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for
circumcision in boys. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003005
Interventions
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
SUPPORTING ANNOTATIONS: "They were randomly allocated to one of two groups to
receive caudal or penile block immediately before surgery."
COMMENTSLikely random allocation however unclear sequence generation
COMMENTS: No information about allocation concealment
SUPPORTING ANNOTATIONS: "analgesia was assessed continuously for five hours by the
anaesthetist (JW) who had conducted the preoperative interview and induced anaesthesia;
she had then left the anaesthetic room so that she did not know which type of analgesia had
been used."
COMMENTS: Participants/parents likely blinded due to procedure and JW likely blinded.
Participants/parents likely blinded due to procedure and JW likely blinded
SUPPORTING ANNOTATIONS: "analgesia was assessed continuously for five hours by the
anaesthetist (JW) who had conducted the preoperative interview and induced anaesthesia;
she had then left the anaesthetic room so that she did not know which type of analgesia had
been used. Before the child left hospital his parents received a form for assessment of
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Low risk
Blinding of outcome assessment (detection bias) Low risk
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18-Dec-2019
analgesia at home and some paracetamol. The table shows the results. The time from
administration of the block to first evidence of pain was assessed by the anaesthetist (in
hospital) or parent (at home), the need for supplemental analgesia in hospital (papa- veretum)
by the anaesthetist, and the quality of the night's sleep and need for paracetamol after
discharge by the parents. Statistical analysis was per- formed using a single tailed t test and
x2 tests with</b> Yates's correction."
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Unclear risk
Low risk
COMMENTS: No information about attrition. Likely no missing data nor drop outs. No
information about attrition. Likely no missing data nor drop outs
COMMENTS: Not reffering to a protocol but report relevant outcomes No protocol however,
relevant outcomes reported. No information about how outcomes (pain and quality of sleep)
were monitored.
COMMENTS: No reasons to suspect other sources of bias
Other bias
Low risk
Williamson 1983
Methods
Participants
Interventions
RCT
30 male NB; BW = 2500 - 4000 g; 24 - 72 hr age; FT; Apgar score > 7; systolic BP > 40 mm Hg
0.6 to 0.8 1% ml lidocaine DPNB (n=20)
no treatment control (n=10)
4 min WT
TcpO2, time cry; HR, RR
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Unclear risk
Support for judgement
RTICLES 37 <b>domly assigned to the test group and ten to the control group, by the
assignment of each eligible cluster of three in the order: control, anesthetized, and
anesthetized. Ten unanesthetized infants had previously been studied during circumcision by
Rawlings et al5; therefore, only ten additional con- trol infants were included. The mean values
for each of the screening criteria by group are shown in Table 1. There was no significant
difference be- tween groups for any of the entry data categories.</b> Each infant studied was
continuouslyCOMMENTSsequence generation not described
No information on allocation concealment
No information about blinding
ontinuous changes from the five-minute base line in the transcutaneous Po2, heart rate,
respira- tory rate, and crying were recorded for each infant in 30-second intervals.</b> Group
means were compared byCOMMENTSNo information about blinding of outcome assessors
Objective measures
No information about missing data. Likely no drop outs.
Not reffering to a portocol but report on relevant outcomes No protocol. Apparently thorough
outcome reporting of PO2, HR, respiration and crying.
each eligible cluster of three <b>in the order: control, anesthetized, and anesthetized. Ten
unanesthetized infants had previously been studied during circumcision by Rawlings et al5;
therefore, only ten additional con- trol infants were included. The mean values for each of the
screening criteria by group are shown in Table 1. There was no significant difference be-
tween groups for any of the entry data categories. Each</b> infant studied was continuously
monitored
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
Williamson 1986
Methods
Participants
Interventions
RCT
24 male NB; Apgar > 7; BW 2500 - 4500 g; FT; 24 - 72 hr age; normal physical exam
lidocaine DPNB (n= 11)
no treatment control (n=13)
5 min WT
plasma cortisol pre and 30 min post circumcision
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
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Omskæring - PICO 2 Anæstesi
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
18-Dec-2019
SUPPORTING ANNOTATIONS: "13 infants were <b>assigned by a random numbers table to
Group</b> A, controls who were circumcised 13 infants were assigned by a random numbers
table to Group A, controls who were circumcised in the usual manner without</b> anesthesia.
Eleven were assigned toare listed in Table 1. <b>There was no difference between the four
baseline means (ANOVA, F = 0.39, df = 3, p = >0.05), indicating the infants started in
equivalent adrenal states.</b> Both Groups A and B
COMMENTS: No information on allocation concealment
SUPPORTING ANNOTATIONS: "All operations were performed by the principal investigator in
an identical manner at approximately the same hour of the afternoon." "The DPNB of Kirya
and Werthmann5 5 was administered in Group B at a dose of 2 mg of lidocaine per kilogram of
body weight, approximately 5 minutes prior to operation. Both Groups A and B were
circumcised in the usual manner by the bloodless circumcision clamp (Gomco) method. All
operations were performed by the principal investigator in an identical manner at
approximately the same hour of the afternoon."
COMMENTS: No information on outcome assessors but report objective measures.
COMMENTS: Unclear if all are inlcuded in analysis. No information. Likely no drop outs and
complete data
COMMENTS: Not reffering to a protocol but report on relevant outcomes
COMMENTS: No reasons to suspect other sources of bias.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Williamson 1997
Methods
Participants
Interventions
Outcomes
Notes
RCT
30 male NB; FT; >/= 24 hr age; BW 2500- 4500g; Apgar > 7
lidocaine DPNB (n=20)
no treatment control (n=10)
TcPO2, RR, HR, cardiac rhythm, cry time and type
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
Woodman 1999
Methods
Participants
Interventions
RCT
61 male NB; Apgar > 7; FT; BW > 2500 g; 6-72 hr age
1 g (1 ml) LP cream (n=20)
30% lidocaine cream (n=20)
placebo cream (n=21)
creams applied 1 hr prior and covered with occlusive dressing
HR; time crying; O2sat
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
Sample characteristics were similar for each study group (Table 1). Differences before the
procedure were controlled by randomization. The three groups were not significantly different
in birth weight, age, baseline pulse, baseline PO 2, baseline BP, time to complete the
procedure, and type of delivery. Apgar scores at 1 and 5 minutes were similar across groups
(P .57).The 61 infants were assigned to one of three groups using a computer-generated
random list:
No information allocation concealment
Allocation concealment (selection bias)
Unclear risk
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2317998_0044.png
Omskæring - PICO 2 Anæstesi
Blinding of participants and personnel
(performance bias)
Low risk
18-Dec-2019
control), and C (5% lidocaine-prilocaine). <b>The investigator was blinded to the contents of
each vial until completion of statistical analysis.</b> Enrollment criteria were listed onAll
circumcisions were done by the same operator.COMMENTSInvestigator likely blinded
throughout the study.
All procedures were coded by the same operator, who was blinded to the
analgesics.COMMENTSOperator and investigator likely blinded throughout the study
Isolated data points missed because of gaps in pulse oximeter readouts were
excluded.COMMENTSNo information on the proportion of excluded data or the handling of
missing data. Likely no drop outs.
Not reffering to a protocol, but report on relevant outcomes.
The study seems free of other sources of bias.
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Unclear risk
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Zahorodny 1998
Methods
Participants
Interventions
RCT
53 healthy male NB
1g LP cream + 2 ml 50% sucrose
1g LP cream + 2 ml H2O
1g placebo cream + 2 ml 50% sucrose
1g placebo cream + 2mL H2O
creams applied 1 hr prior; sucrose or H2O oral 2 min prior
total n=53, allocation not clear
time cry
abstract only - not possible to assess Risk of Bias. Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal
circumcision. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Authors'
judgement
Unclear risk
Unclear risk
Unclear risk
Support for judgement
A randomized, double-blind, placebo control trial. Randomization method not described
EMLA or placebo cream was applied 1 hour prior to procedure; sucrose or sterile water was
given orally, 2 minutes prior to procedure.
Only abstract with no information
Only abstract with no information. Duration of crying during baseline, antiseptic, incision,
clamping and dressing phases was determined from videotapes of the procedure and
compared
Only abstract with no information
Not reffering to a protocol but report on relevant outcomes.
No reason to suspect other bias
Blinding of outcome assessment (detection bias) Unclear risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Unclear risk
Low risk
Low risk
Zahorodny 1999
Methods
Participants
Interventions
RCT
61; healthy male NB
10 ml 50% sucrose via pacifier
10 ml H2O via pacifier
no treatment control
total n=61, allocation not clear
HR, time cry
Abstract. Not possible to assess RoB.
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Authors' judgement
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Unclear risk
Support for judgement
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2317998_0045.png
Omskæring - PICO 2 Anæstesi
Zavras 2014
Methods
Participants
Study design:
Randomized controlled trial
Study grouping:
Parallel group
Baseline Characteristics
Intervention 1
Age:
7.15 (2.47) years
Duration of surgey:
18.74 (1.24) min
Anesthesia duration
: 27.02 (1.1) min
intervention 2
Age:
Duration of surgey:
Anesthesia duration
:
kontrol 1
Age:
6.43 (2.27) years
Duration of surgey:
18.32 (1.25) min
Anesthesia duration
: 26.6 (1.2) min
kontrol 2
Age:
Duration of surgey:
Anesthesia duration
:
Overall
Age:
Duration of surgey:
Anesthesia duration
:
18-Dec-2019
Included criteria:
we enrolled 106 ASA Grade I-II boys in the study, all of whom were scheduled for elective circumcision
(ages ranging from 2 to12 years)
Excluded criteria:
Exclusion criteria included a severe systemic disease, neurological and bleeding diseases, and a
previous unsuccessful circumcision.
Pretreatment:
No differences between groups at baseline
Interventions
Intervention Characteristics
Intervention 1
Description:
Group A (53 patients) received SCRB with 0.25% levobupivacaine (0.5% levobupivacaine diluted in
normal saline, Chirocaine®, Abbott Laboratories, Ltd) with a dose of 0.1 ml/kg (total dose 0.5 mg/kg) injected around
the base of the penis[7] plus rectal paracetamol of 30 mg/kg
Dose:
Duration:
Follow-up time:
intervention 2
Description:
group B (53 patients, control group) received a paracetamol suppository of 30 mg/kg.
Dose:
Duration:
Follow-up time:
kontrol 1
Description:
group B (53 patients, control group) received a paracetamol suppository of 30 mg/kg.
Dose:
Duration:
Follow-up time:
kontrol 2
Description:
Dose:
Duration:
Follow-up time:
Outcomes
Serious adverse events
Outcome type:
DichotomousOutcome
Adverse events
Outcome type:
DichotomousOutcome
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Authors'
judgement
Unclear risk
Low risk
Support for judgement
Judgement Comment: Sequence generation not described
Judgement Comment: Following induction of anesthesia and before the start of surgery, the
children were randomized into two groups, by the closed-envelope technique.
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2317998_0046.png
Omskæring - PICO 2 Anæstesi
Blinding of participants and personnel
(performance bias)
High risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
Low risk
Low risk
Low risk
18-Dec-2019
Judgement Comment: Not clear how patients og personnel were blinded to the intervention.
Personnel could not be blinded
Judgement Comment: A nurse blinded to group allocation observed the children and assessed
outcomes: Pain scores, need for analgesia, post-anesthetic, and surgical complications.
Judgement Comment: It seems all included participants were included in the analysis
Judgement Comment: Not reffering to a protocol. However, reports on relevant outcomes.
Judgement Comment: No other sources of bias. Conflict of Interest: None.Der bliver også
udført forskellige operationsteknikker.
Zolnoski 1993
Methods
Participants
Interventions
RCT
20 male NB, 8 - 120 hr age, FT; no maternal medication, BW > 2700 g, 5 min Apgar >/= 7
2.4 ml 24% sucrose (n=10)
2.4 ml water via syringe (n=10)
given 3 min prior
Cry time; HR
Please see Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217.
Outcomes
Notes
Risk of bias table
Bias
Random sequence generation (selection bias)
Authors'
judgement
Low risk
Support for judgement
SUPPORTING ANNOTATIONS: "infants received sucrose via syringe. <b>Random
assignment to groups was accomplished by a lottery-type selection. The numbers 1</b> 15"
COMMENTS: randomly assigned to either the treatment group or the control group. Random
assignment to groups was accomplished by a lottery-type selection
COMMENTS: No information on allocation concealment
COMMENTS: Both the sucrose and sterile water were placed in the buccal mucosa to prevent
aspiration
SUPPORTING ANNOTATIONS: "The tapes were later evaluated for the duration of crying in
minutes and seconds by a coder who was unaware of</b> 11nvasive"
COMMENTS: All data information was collected on a data collection form developed by the
researcher .Crying means any audible crying vocalizations exclusive of fussing or whimpering
sounds. The tapes were later evaluated for the duration of crying in minutes and seconds by a
coder who was unaware of group assignments. The coder was a senior nursing student who
had agreed to participate
SUPPORTING ANNOTATIONS: "and 3 infants were bottle-fed. <b>All infants who participated
in the study were able to complete the study without being eliminated or excluded.</b>
Hypotheses Testing The hypotheses were"
COMMENTS: all children included in analysis
Comments: Not reffering to a protocol but report relevant outcomes
COMMENTS: Master thesis, one author/investigator, pilot study.
Allocation concealment (selection bias)
Blinding of participants and personnel
(performance bias)
Unclear risk
Unclear risk
Blinding of outcome assessment (detection bias) Low risk
Incomplete outcome data (attrition bias)
Low risk
Selective reporting (reporting bias)
Other bias
Footnotes
Low risk
Low risk
Characteristics of excluded studies
Footnotes
Characteristics of studies awaiting classification
Footnotes
Characteristics of ongoing studies
Footnotes
References to studies
Included studies
Ahiskalioglu 2018
Ahiskalioglu, A.; Yayik, A. M.; Ahiskalioglu, E. O.; Ekinci, M.; Gölboyu, BE; Celik, E. C.; Alici, H. A.; Oral, A.; Demirdogen, S. O.. Ultrasound-guided versus
conventional injection for caudal block in children: a prospective randomized clinical study. Journal of clinical anesthesia 2018;44(Journal Article):91 96. [DOI:
10.1016/j.jclinane.2017.11.011]
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Omskæring - PICO 2 Anæstesi
Al Qahtani 2014
[Empty]
18-Dec-2019
Anouar 2016
Anouar, J.; Mohamed, S.; Sofiene, A.; Jawhar, Z.; Sahar, E.; Kamel, K.. The analgesic effect of clonidine as an adjuvant in dorsal penile nerve block. 2016;23(Journal
Article):213. [DOI: 10.11604/pamj.2016.23.213.5767]
Arnett 1990
[Empty]
Awori 2019
Awori, Q.; Li, P. S.; Lee, R. K.; Ouma, D.; Oundo, M.; Barasa, M.; Obura, N.; Mwamkita, D.; Simba, R.; Oketch, J.. Use of topical versus injectable anaesthesia for
ShangRing circumcisions in men and boys in Kenya: results from a randomized controlled trial. 2019;14(8). [DOI: 10.1371/journal.pone.0218066]
Benini 1993
[Empty]
Beyaz 2011
[Empty]
Blass 1991 A
[Empty]
Blass 1991 B
[Empty]
Bramwell 1982
[Empty]
Butler O'Hara 1998
[Empty]
Canakci 2017
Canakci, E.; Yagan, O.; Tas, N.; Mutlu, T.; Cirakoglu, A.; Benli, E.. Comparison of preventive analgesia techniques in circumcision cases: dorsal penile nerve block,
caudal block, or subcutaneous morphine? 2017;67(2):159 165. [DOI: ]
Concha 1994
[Empty]
Dixon 1984
[Empty]
Dostbil 2014
Dostbil, A.; Gursac Celik, M.; Aksoy, M.; Ahiskalioglu, A.; Celik, E. C.; Alici, H. A.; Ozbey, I.. The effects of different doses of caudal morphine with levobupivacaine on
postoperative vomiting and quality of analgesia after circumcision. Anaesthesia and Intensive Care 2014;42(2):234 238. [DOI: 10.1177/0310057X1404200211]
Garry 2006
Garry, D. J.; Swoboda, E.; Elimian, A.; Figueroa, R.. A video study of pain relief during newborn male circumcision. Journal of perinatology : official journal of the
California Perinatal Association 2006;26(2):106-110. [DOI: 7211413 [pii]]
Gauntlett 2003
[Empty]
Gulec 2015
Gulec, H.; Sahin, S.; Ozayar, E.; Degerli, S.; Bercin, F.; Ozdemir, O.. Ketamine-propofol sedation in circumcision. 2015;65(5):367 370. [DOI:
10.1016/j.bjane.2014.03.002]
Haliloglu 2013
[Empty]
Hardwick Smith 1998
[Empty]
Herschel 1998
[Empty]
Holliday 1999
[Empty]
Holve 1983
[Empty]
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Omskæring - PICO 2 Anæstesi
Howard 1994
[Empty]
18-Dec-2019
Howard 1999
[Empty]
Joyce 2001
[Empty]
Karasu 2018
[Empty]
Kass 2001
[Empty]
Kaufman 2002
[Empty]
KazakBengisun 2012
[Empty]
Kurtis 1999 A
[Empty]
Kurtis 1999 B
[Empty]
Lander 1997
[Empty]
Lehr 2005
Lehr, V. T.; Cepeda, E.; Frattarelli, D. A.; Thomas, R.; LaMothe, J.; Aranda, J. V.. Lidocaine 4% cream compared with lidocaine 2.5% and prilocaine 2.5% or dorsal
penile block for circumcision. American Journal of Perinatology 2005;22(5):231-237. [DOI: 10.1055/s-2005-871655 [doi]]
Lunn 1979
[Empty]
Macke 2001
[Empty]
Mak 2001
[Empty]
Marchette 1989
[Empty]
Marchette 1991
[Empty]
Martin 1982
[Empty]
Masciello 1990
[Empty]
Maxwell 1987
[Empty]
May 1982
[Empty]
Mohan 1998
[Empty]
Mudge 1989
[Empty]
Mujeep 2013
[Empty]
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Omskæring - PICO 2 Anæstesi
Naja 2011
[Empty]
18-Dec-2019
Newton 1999
[Empty]
Panda 2011
[Empty]
Sharara Chami 2017
Sharara-Chami, R.; Lakissian, Z.; Charafeddine, L.; Milad, N.; El-Hout, Y.. Combination Analgesia for Neonatal Circumcision: a Randomized Controlled Trial.
Pediatrics 2017;140(6). [DOI: 10.1542/peds.2017-1935]
South 2005
South, M. M.; Strauss, R. A.; South, A. P.; Boggess, J. F.; Thorp, J. M.. The use of non-nutritive sucking to decrease the physiologic pain response during neonatal
circumcision: a randomized controlled trial. American Journal of Obstetrics and Gynecology 2005;193(2):537-42; discussion 542-3. [DOI: S0002-9378(05)00490-4 [pii]]
Spencer 1992
[Empty]
Stang 1988 A
[Empty]
Stang 1988 B
[Empty]
Stang 1997
[Empty]
Taddio 1997
[Empty]
Teunkens 2018
[Empty]
Tutuncu 2018
Tutuncu, A. C.; Kendigelen, P.; Ashyyeralyeva, G.; Altintas, F.; Emre, S.; Ozcan, R.; Kaya, G.. Pudendal Nerve Block Versus Penile Nerve Block in Children
Undergoing Circumcision. 2018;15(3):109 115. [DOI: 10.22037/uj.v0i0.4292]
Vater 1985
[Empty]
Wang 2019
[Empty]
Weatherstone 1993
[Empty]
Weksler 2005
[Empty]
White 1983
[Empty]
Williamson 1983
[Empty]
Williamson 1986
[Empty]
Williamson 1997
[Empty]
Woodman 1999
[Empty]
Zahorodny 1998
[Empty]
Zahorodny 1999
[Empty]
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Omskæring - PICO 2 Anæstesi
Zavras 2014
18-Dec-2019
Zavras, N.; Tsamoudaki, S.; Christianakis, E.; Schizas, D.; Pikoulis, E.; Kyritsi, H.; Chrousos, G.. Ring block with levobupivacaine 0.25% and paracetamol vs.
paracetamol alone in children submitted to three different surgical techniques of circumcision: a prospective randomized study. 2014;8(1):45 50. [DOI:
10.4103/1658-354X.125936]
Zolnoski 1993
Unpublished data only
[Empty]
Data and analyses
1 DPNB versus no treatment or sham
Outcome or Subgroup
1.1 Pain score
1.1.1 infant irritability score
1.1.2 modified behavioral pain scale (MBPS)
1.1.3 author-created behavioural score
1.2 Cry time (by unit)
1.2.1 in %
1.2.2 in seconds
1.2.3 Crying component of behavioural score
1.3 Heart rate (by unit)
1.3.1 in bpm
1.3.2 in bpm change-from-baseline
1.3.3 in % change-from-baseline
1.4 Heart rate (by wait time)
1.4.1 wait time after anesthetic administration
</= 5 min
1.4.2 wait time after anesthetic administration
> 5 min
Studies
3
1
1
1
7
5
1
1
8
3
3
2
7
3
3
Participants
135
49
48
38
249
163
48
38
348
135
135
78
299
158
93
48
348
316
32
293
165
128
30
30
86
38
48
68
38
30
102
48
38
38
Statistical Method
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
-1.76 [-2.31, -1.21]
-1.70 [-2.36, -1.03]
-1.37 [-2.00, -0.74]
-2.40 [-3.25, -1.54]
-1.76 [-2.06, -1.46]
-1.67 [-2.04, -1.29]
-1.97 [-2.67, -1.27]
-1.92 [-2.70, -1.13]
-1.78 [-2.29, -1.27]
-1.60 [-2.00, -1.21]
-1.46 [-2.05, -0.87]
-3.38 [-7.04, 0.28]
-1.87 [-2.50, -1.24]
-1.64 [-2.01, -1.27]
-2.44 [-4.49, -0.40]
-1.98 [-2.69, -1.28]
-1.84 [-2.39, -1.30]
-1.76 [-2.34, -1.19]
-2.51 [-3.46, -1.56]
3.38 [0.46, 6.30]
4.44 [0.55, 8.34]
1.12 [0.40, 1.84]
9.30 [1.75, 16.85]
9.30 [1.75, 16.85]
-0.04 [-0.83, 0.76]
-0.66 [-1.32, -0.01]
0.39 [-0.19, 0.96]
-1.00 [-2.96, 0.97]
-0.03 [-0.66, 0.61]
-2.03 [-2.97, -1.09]
-70.11 [-142.12, 1.91]
-0.54 [-1.08, -0.00]
21.00 [-73.45, 115.45]
Not estimable
1.4.3 wait time after anesthetic administration - 1
other wait time reported
1.5 Heart rate (by clamp)
1.5.1 Gomco
1.5.2 Mogen
1.6 Oxygen saturation (by unit)
1.6.1 in %
1.6.2 in % change-from-baseline
9
8
1
6
4
2
1.7 Transcutaneous oxygen saturation - change 1
from baseline
1.7.1 torr (TcpO2)
1.8 Respiratory rate (by unit)
1.8.1 rpm
1.8.2 in % change-from-baseline
1.9 Systolic blood pressure (by unit)
1.9.1 in mmHg
1.9.2 in % change-from-baseline
1.10 Serum cortisol (nmol/dL) 30 min post
1.11 Salivary cortisol increase (ug/dL) from
baseline to 30 min post
1.12 B-endorphin (pmol/L)
1.13 Adverse events
1
3
1
2
2
1
1
4
1
1
1
Review Manager 5.3
50
B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0051.png
Omskæring - PICO 2 Anæstesi
2 Ring block versus no treatment
Outcome or Subgroup
2.1 Cry time (by unit)
2.1.1 in %
2.1.2 in seconds
2.2 Heart rate (bpm) change-from-baseline
Studies
2
1
1
1
Participants
63
23
40
23
40
40
Statistical Method
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
18-Dec-2019
Effect Estimate
-1.40 [-2.44, -0.36]
-2.01 [-3.05, -0.98]
-0.94 [-1.60, -0.29]
-29.27 [-52.94, -5.60]
3.84 [-0.94, 8.62]
-5.69 [-16.02, 4.64]
2.3 Oxygen saturation (%) change-from-baseline 1
2.4 Respiratory rate (rpm) change-from-baseline 1
3 EMLA versus placebo or no treatment
Outcome or Subgroup
3.1 Pain score
3.1.1 neonatal facial coding system (NFCS)
3.1.2 NFCS - author-devised summary score
3.2 Cry time (by unit)
3.2.1 in %
3.2.2 in minutes
3.2.3 percent increase in time crying
3.3 Heart rate (by unit)
3.3.1 in bpm
3.3.2 in bpm change-from-baseline
3.4 Oxygen saturation (%)
3.5 Respiratory rate (rpm)
3.6 Systolic blood pressure (mmHg)
change-from-baseline
3.7 Diastolic blood pressure (mmHg)
change-from-baseline
Studies
2
1
1
6
3
2
1
5
3
2
3
1
1
1
Participants
86
27
59
189
79
51
59
143
78
65
78
10
38
38
Statistical Method
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-0.59 [-1.02, -0.16]
-0.82 [-1.61, -0.03]
-0.49 [-1.01, 0.03]
-0.78 [-1.08, -0.48]
-0.81 [-1.40, -0.23]
-0.57 [-1.13, -0.01]
-0.95 [-1.49, -0.41]
-14.59 [-19.34, -9.84]
-15.80 [-21.50, -10.10]
-13.46 [-26.41, -0.50]
2.63 [-1.26, 6.51]
-4.31 [-20.79, 12.17]
-3.00 [-15.50, 9.50]
-5.00 [-23.60, 13.60]
4 Topical lidocaine versus placebo
Outcome or Subgroup
4.1 Pain score
Studies
1
25
85
85
85
Participants
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
30
Mean Difference (IV, Random, 95% CI)
Effect Estimate
Subtotals only
-8.00 [-22.90, 6.90]
-59.75 [-99.14, -20.36]
-9.18 [-14.66, -3.71]
-0.50 [-1.75, 0.75]
No totals
-49.00 [-88.73, -9.27]
4.1.1 % change- from-baseline in time spent in 1
Brazelton state 6 (full cry)
4.2 Cry time (s)
4.3 Heart rate (bpm)
4.4 Oxygen saturation (%)
4.5 Respiratory rate (rpm)
4.6 B-endorphin (pg/mL)
2
2
2
1
1
5 Sucrose versus water or no treatment
Outcome or Subgroup
5.1 Pain score
5.1.1 behavioral distress score
5.1.2 modified behavioral pain scale (MBPS)
5.2 Cry time (by unit)
5.2.1 in %
5.2.2 in seconds
5.3 Heart rate (by unit)
5.3.1 in bpm
5.3.2 in bpm change-from-baseline
Studies
2
1
1
5
3
2
3
2
1
Participants
87
40
47
123
56
67
146
67
79
Statistical Method
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-0.48 [-1.46, 0.49]
-1.00 [-1.66, -0.33]
0.00 [-0.57, 0.57]
-0.30 [-1.16, 0.57]
-1.03 [-2.39, 0.33]
0.56 [0.07, 1.04]
-2.45 [-11.01, 6.11]
2.16 [-5.45, 9.78]
-9.70 [-17.72, -1.68]
Review Manager 5.3
51
B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0052.png
Omskæring - PICO 2 Anæstesi
5.4 Oxygen saturation (by unit)
5.4.1 in %
5.4.2 in % change-from-baseline
5.5 Serum cortisol (nmol/dL) 30 min post
2
1
1
1
126
47
79
40
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
18-Dec-2019
1.26 [-2.68, 5.21]
-0.83 [-3.07, 1.41]
3.20 [1.59, 4.81]
68.90 [-53.93, 191.73]
6 Acetaminophen versus placebo
Outcome or Subgroup
6.1 Pain / behavior score
6.1.1 comfort score - change from baseline
score at 30 min post
6.1.2 Nursing Child Assessment Feeding
Scale (NCAFS) - total infant score
6.2 Cry time (%)
6.3 Heart rate (bpm)
6.4 Respiratory rate (rpm)
Studies
2
1
1
2
2
1
Participants
104
44
60
104
104
44
Statistical Method
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
0.39 [-0.18, 0.95]
0.08 [-0.51, 0.67]
0.66 [0.14, 1.18]
-2.03 [-9.80, 5.74]
2.27 [-2.89, 7.44]
-3.73 [-11.00, 3.54]
7 DPNB versus EMLA
Outcome or Subgroup
7.1 Pain score
7.1.1 neonatal infant pain scale (NIPS)
7.1.2 behavioral distress score
7.2 Cry time (%)
7.3 Heart rate (by unit)
7.3.1 in bpm
7.3.2 in bpm change-from-baseline
7.4 Heart rate by wait time
7.4.1 wait time after anesthetic administration
</= 5 min
7.4.2 wait time after anesthetic administration
> 5 min
7.5 Respiratory rate (rpm)
7.6 Adverse events
Studies
3
2
1
1
3
1
2
3
2
1
1
3
104
29
60
91
Participants
204
144
60
29
133
60
73
Statistical Method
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
-0.69 [-1.70, 0.31]
-0.79 [-2.66, 1.08]
-0.56 [-1.08, -0.05]
-10.00 [-29.74, 9.74]
-16.11 [-40.33, 8.10]
-7.90 [-15.52, -0.28]
-20.06 [-60.47, 20.35]
Subtotals only
-1.35 [-3.04, 0.33]
0.05 [-0.68, 0.78]
-2.90 [-7.47, 1.67]
1.11 [0.07, 18.05]
8 DPNB versus local block
Outcome or Subgroup
8.1 Serum cortisol (nmol/dL) 30 min post
Studies
1
Participants
18
Statistical Method
Mean Difference (IV, Random, 95% CI)
Effect Estimate
306.27 [141.33, 471.21]
9 DPNB versus ring block
Outcome or Subgroup
9.1 Cry time (%)
9.2 Heart rate (bpm) change-from-baseline
Studies
1
1
Participants
26
26
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
6.33 [-15.94, 28.60]
4.43 [-14.42, 23.28]
10 DPNB versus sucrose
Outcome or Subgroup
10.1 Pain score
10.1.1 modified behavioral pain scale
10.2 Cry time (s)
10.3 Heart rate (by unit)
10.3.1 in bpm
10.3.2 in bpm change-from-baseline
Studies
1
1
1
2
1
1
Participants
47
47
47
126
47
79
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-3.23 [-4.65, -1.81]
-3.23 [-4.65, -1.81]
-166.00 [-210.54, -121.46]
-32.85 [-63.89, -1.81]
-49.08 [-61.72, -36.44]
-17.40 [-25.47, -9.33]
Review Manager 5.3
52
B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0053.png
Omskæring - PICO 2 Anæstesi
10.4 Oxygen saturation (by unit)
10.4.1 in %
10.4.2 in % change-from-baseline
2
1
1
126
47
79
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
18-Dec-2019
1.13 [-4.11, 6.38]
3.85 [2.06, 5.64]
-1.50 [-2.75, -0.25]
11 Ring block versus EMLA
Outcome or Subgroup
11.1 Heart rate (bpm) change-from-baseline
11.2 Cry time (%)
Studies
1
1
Participants
27
27
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-3.17 [-20.84, 14.50]
-16.33 [-36.15, 3.49]
12 Buffered lidocaine DPNB versus plain lidocaine DPNB
Outcome or Subgroup
12.1 Pain score
12.1.1 behavioral distress score
12.2 Cry time (%)
12.3 Heart rate (bpm)
12.4 Oxygen saturation (%)
12.5 Serum cortisol (nmol/dL) 30 min post
Studies
1
1
1
1
1
1
40
194
194
194
40
Participants
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
Subtotals only
0.10 [-0.30, 0.50]
9.00 [-11.71, 29.71]
-4.20 [-10.51, 2.11]
0.50 [-0.87, 1.87]
35.80 [-105.62, 177.22]
13 EMLA versus 30% topical lidocaine
Outcome or Subgroup
13.1 Cry time (s)
13.2 Heart rate (bpm)
13.3 Oxygen saturation (%)
Studies
1
1
1
Participants
40
40
40
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-17.00 [-75.00, 41.00]
-11.88 [-19.40, -4.36]
-0.17 [-1.44, 1.10]
14 EMLA versus sucrose
Outcome or Subgroup
14.1 Cry time (%)
14.2 Heart rate (bpm)
14.3 Oxygen saturation (%)
14.4 Systolic blood pressure (mmHg)
14.5 Diastolic blood pressure (mmHg)
14.6 Respiratory rate (cycles/min) during
circumcision
14.7 N-PASS score after 5 min
14.8 N-PASS score during circumcision
Studies
1
2
2
1
1
1
1
1
Participants
26
101
101
41
41
60
60
60
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-10.00 [-26.74, 6.74]
-6.76 [-11.87, -1.65]
1.02 [-2.42, 4.47]
Not estimable
Not estimable
-1.90 [-4.00, 0.20]
1.40 [0.74, 2.06]
2.40 [1.85, 2.95]
15 EMLA versus music
Outcome or Subgroup
15.1 Cry time (min)
15.2 Heart rate (bpm)
15.3 Oxygen saturation (%)
15.4 Respiratory rate (rpm)
Studies
1
1
1
1
Participants
12
12
12
12
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
0.38 [-3.68, 4.44]
2.31 [-15.99, 20.61]
0.19 [-3.56, 3.94]
1.52 [-13.60, 16.64]
16 Music versus no treatment
Outcome or Subgroup
16.1 Cry time (min)
16.2 Heart rate (bpm)
16.3 Oxygen saturation (%)
16.4 Respiratory rate (rpm)
Studies
1
1
1
1
Participants
12
12
12
12
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-1.58 [-5.81, 2.65]
-7.89 [-41.37, 25.59]
2.51 [-0.62, 5.64]
-5.83 [-21.41, 9.75]
Review Manager 5.3
53
B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0054.png
Omskæring - PICO 2 Anæstesi
17 Caudal analgesia versus parenteral analgesia
Outcome or Subgroup
17.1 Need for analgesia
17.2 Nausea or vomiting
Studies
4
4
Participants
235
235
Statistical Method
Risk Ratio (M-H, Random, 95% CI)
Risk Difference (M-H, Fixed, 95% CI)
18-Dec-2019
Effect Estimate
0.41 [0.12, 1.43]
-0.08 [-0.17, 0.01]
18 Bupivacaine + clonidine vs. Bupivacaine (DPNB)
Outcome or Subgroup
18.1 Adverse events
18.8 Pain
18.9 Need for analgesia
Studies
1
1
1
40
40
Participants
Statistical Method
Risk Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
No totals
-0.60 [-1.13, -0.07]
0.42 [0.18, 0.96]
19 Caudal analgesia versus rectal or intravenous
Outcome or Subgroup
19.1 Need for any analgesia (rescue or other)
19.2 Need for rescue analgesia
19.3 Other analgesia
19.3.1 acetaminophen before discharge
19.3.2 paracetamol up to 2 hours postop
19.3.3 paracetamol on day of operation
19.4 Complications
19.4.1 nausea and vomiting
19.4.2 bleeding
19.4.3 bruising of skin/at needle site
19.5 Hospital stay
19.5.1 recovery room stay
Studies
2
1
2
1
1
1
2
2
1
1
1
1
164
124
124
40
124
124
Participants
164
124
Statistical Method
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Other data
Other data
Effect Estimate
0.81 [0.51, 1.27]
4.84 [0.24, 98.88]
Subtotals only
0.60 [0.35, 1.04]
0.19 [0.01, 3.96]
1.03 [0.75, 1.41]
Subtotals only
0.88 [0.14, 5.53]
0.97 [0.06, 15.14]
2.91 [0.12, 69.99]
No numeric data
No numeric data
20 Caudal analgesia versus dorsal nerve penile block
Outcome or Subgroup
20.1 Need for any analgesia (rescue or other)
20.2 Need for rescue analgesia
20.3 Other analgesia
20.3.1 paracetamol up to 2 hours postop
20.3.2 paracetamol on day of operation
20.3.3 paracetamol at home
20.4 Time to first analgesia demand
20.5 Pain
20.6 Complications
20.6.1 nausea and vomiting
20.6.2 motor block
20.6.3 motor/leg weakness
20.6.4 bleeding
20.6.5 bruising of skin/at needle site
20.6.6 tachycardia
20.6.7 phonation
20.6.8 movement
20.6.9 eating disturbance
20.6.10 sleep disturbance
20.6.11 behavioural disturbance
20.6.12 urinary retention
20.6.13 Aspiration of blood
20.6.14 Edema
Studies
4
4
2
1
1
1
3
6
10
6
3
2
3
3
1
1
1
1
1
1
1
1
2
443
251
110
277
274
100
100
100
57
57
57
57
47
151
126
126
100
211
441
Participants
336
336
Statistical Method
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Std. Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
1.25 [0.64, 2.44]
2.40 [0.60, 9.59]
Subtotals only
0.33 [0.01, 8.03]
0.92 [0.68, 1.24]
1.67 [0.66, 4.24]
2.95 [-73.98, 79.88]
0.54 [-0.17, 1.25]
Subtotals only
1.68 [0.76, 3.70]
17.00 [1.01, 286.82]
10.07 [1.25, 81.32]
0.48 [0.08, 2.70]
0.34 [0.07, 1.82]
2.00 [0.53, 7.56]
3.00 [0.32, 27.87]
0.20 [0.01, 4.06]
0.89 [0.27, 2.97]
1.30 [0.73, 2.29]
0.91 [0.45, 1.85]
Not estimable
0.32 [0.01, 7.48]
Not estimable
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0055.png
Omskæring - PICO 2 Anæstesi
20.6.15 Hematoma
20.6.16 uninary retention
20.6.17 Postop agitation
20.6.18 Numbness of lower limbs
20.11 SAE
20.12 Heart rate
3
3
3
1
3
2
241
191
211
90
241
130
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
18-Dec-2019
Not estimable
3.00 [0.13, 69.52]
0.50 [0.05, 5.22]
9.82 [0.54, 177.19]
Not estimable
-1.50 [-10.14, 7.13]
21 Topical vs injectable anaesthesia
Outcome or Subgroup
21.2 Adverse events
21.8 Pain
Studies
1
1
344
Participants
Statistical Method
Risk Ratio (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
No totals
0.10 [-0.01, 0.21]
22 GA DPNB+bupivacaine vs.GA+morphine
Outcome or Subgroup
22.2 Adverse events
22.3 Heart rate
22.8 Pain
Studies
0
1
1
40
40
Participants
Statistical Method
Risk Ratio (IV, Fixed, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
No totals
-6.80 [-18.00, 4.40]
-0.12 [-0.76, 0.52]
24 GA+morphine vs. GA+caudal block+bupivacaine
Outcome or Subgroup
24.2 Adverse events
24.3 Heart rate
24.8 Pain
Studies
0
1
1
40
40
Participants
Statistical Method
Risk Ratio (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
No totals
-10.85 [-21.44, -0.26]
-1.58 [-2.14, -1.02]
25 Caudal morphine 7.5 (with levobupivacaine) vs Caudal morphine 10.0 (with levobupivacaine)
Outcome or Subgroup
25.2 Adverse events
25.9 Need for analgesia
Studies
1
1
160
Participants
Statistical Method
Risk Ratio (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
No totals
1.43 [0.78, 2.63]
26 Caudal morphine 7.5 (with levobupivacaine) vs Caudal morphine 15.0 (with levobupivacaine)
Outcome or Subgroup
26.2 Adverse events
26.9 Need for analgesia
Studies
1
1
Participants
160
160
Statistical Method
Risk Ratio (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
0.29 [0.10, 0.83]
2.50 [1.17, 5.34]
27 Caudal morphine 10 (with levobupivacaine) vs Caudal morphine 15.0 (with levobupivacaine)
Outcome or Subgroup
27.2 Adverse events
27.9 Need for analgesia
Studies
1
1
Participants
160
160
Statistical Method
Risk Ratio (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
0.71 [0.34, 1.51]
1.75 [0.78, 3.94]
28 Midazolam+ketamin vs. fentanyl+licaine+propofol
Outcome or Subgroup
28.1 Serious adverse events
Studies
1
Participants
Statistical Method
Risk Difference (IV, Random, 95% CI)
Effect Estimate
No totals
29 EMLA vs. EMLA+Sucrose
Outcome or Subgroup
29.3 Heart rate
29.5 Oxygen saturation %
29.8 Pain
29.11 Crying time (s)
Studies
1
1
1
1
Participants
30
30
30
30
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
11.27 [0.39, 22.15]
1.15 [-1.15, 3.45]
2.40 [1.73, 3.07]
28.90 [18.91, 38.89]
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
30 EMLA vs EMLA+sucrose+DNPB
Outcome or Subgroup
30.2 Adverse events
30.3 Heart rate
30.5 Oxygen saturation
30.8 Pain
30.11 Crying time
Studies
0
1
1
1
1
30
30
30
0
Participants
Statistical Method
Risk Ratio (IV, Fixed, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
18-Dec-2019
Effect Estimate
No totals
16.75 [6.07, 27.43]
2.56 [0.34, 4.78]
2.50 [1.83, 3.17]
Not estimable
31 Circumcision: sucrose 50% solution on a premature nipple containing a 2 x 2 cm sterile gauze pad moistened by the
fluid versus no treatment
Outcome or Subgroup
31.1 Change from baseline in heart rate
(beats/min)
Studies
1
Participants
56
Statistical Method
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-9.70 [-19.82, 0.42]
32 EMLA vs. EMLA+sucrose+ring block
Outcome or Subgroup
32.3 Heart rate
32.5 Oxygen saturation %
32.8 Pain
32.11 Crying time (s)
Studies
1
1
1
1
Participants
30
30
30
0
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
24.03 [14.81, 33.25]
1.89 [-0.31, 4.09]
3.05 [2.40, 3.70]
Not estimable
33 Circumcision: sucrose (24%) versus EMLA + sucrose (24%)
Outcome or Subgroup
33.1 N-PASS score during circumcision
33.2 N-PASS score after 5 min
33.3 Heart rate (beats/min) during circumcision
33.4 Respiratory rate (cycles/min)
Studies
1
1
1
1
Participants
60
60
60
60
60
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
3.00 [2.42, 3.58]
1.20 [0.49, 1.91]
12.00 [6.62, 17.38]
0.60 [-1.77, 2.97]
3.40 [2.41, 4.39]
33.5 Oxygen saturation (%) during circumcision 1
34 Circumcision: sucrose solution (50%) on a premature nipple containing a 2 x 2 cm sterile gauze pad moistened by
the fluid versus dorsal penile nerve block (DPNB)
Outcome or Subgroup
34.1 Change in heart rate (beats/min) from
baseline
Studies
1
Participants
79
Statistical Method
Mean Difference (IV, Random, 95% CI)
Effect Estimate
17.40 [11.16, 23.64]
35 Circumcision: pacifier dipped in sucrose (24%) + DPNB versus pacifier dipped in water + DPNB
Outcome or Subgroup
35.1 Mean Behavioral Distress Scale scores
during circumcision
35.2 Mean plasma cortisol levels n mol/dL
Studies
1
1
Participants
40
40
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-0.67 [-1.08, -0.26]
68.90 [-53.93, 191.73]
36 EMLA+sucrose vs. EMLA+sucrose+DPNB
Outcome or Subgroup
36.2 Adverse events
36.3 Heart rate
36.5 Oxygen saturation %
36.8 Pain
36.11 Crying time (s)
Studies
0
1
1
1
1
40
40
40
40
Participants
Statistical Method
Risk Ratio (IV, Fixed, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
No totals
5.48 [-4.42, 15.38]
1.41 [0.19, 2.63]
0.10 [-0.72, 0.92]
4.94 [-3.24, 13.12]
37 EMLA+sucrose VS EMLA+sucrose+RB
Outcome or Subgroup
Studies
Participants
Statistical Method
Effect Estimate
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Omskæring - PICO 2 Anæstesi
37.2 Adverse events
37.3 Heart rate
37.5 Oxygen saturation %
37.8 Pain
37.11 Crying time (s)
0
1
1
1
1
40
40
40
0
Risk Ratio (IV, Fixed, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
No totals
18-Dec-2019
12.76 [4.46, 21.06]
0.74 [-0.45, 1.93]
0.65 [-0.16, 1.46]
Not estimable
38 EMLA+sucrose+DPNB vs EMLA+sucrose+RB
Outcome or Subgroup
38.3 Heart rate
38.5 Oxygen saturation %
38.8 Pain
38.11 Crying time (s)
Studies
1
1
1
1
Participants
40
40
40
0
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
7.28 [-0.77, 15.33]
-0.67 [-1.70, 0.36]
0.55 [-0.26, 1.36]
Not estimable
39 Ring block+levobupivacaine+parcetamol vs. paracetamol
Outcome or Subgroup
39.2 Adverse events
39.3 Heart rate (bpm)
39.8 Pain
39.9 Need for analgesia
39.10 Nausea and vomiting
Studies
0
1
1
1
1
106
106
106
106
Participants
Statistical Method
Risk Ratio (IV, Fixed, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
No totals
0.40 [-2.95, 3.75]
-0.19 [-0.55, 0.17]
Not estimable
2.00 [0.38, 10.46]
40 LMX4 versus EMLA
Outcome or Subgroup
40.1 Adverse events
Studies
1
Participants
36
Statistical Method
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
0.50 [0.05, 5.04]
41 LMX4 versus DPNB
Outcome or Subgroup
41.1 Adverse events
Studies
1
Participants
36
Statistical Method
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
3.00 [0.13, 69.09]
42 DPNB+Non nutritive sucking VS. DPNB
Outcome or Subgroup
42.1 Heart rate (bpm)
42.2 Cortisol levels (saliva)
42.3 Pain
42.4 Crying time
Studies
1
1
1
1
Participants
43
43
0
43
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Random, 95% CI)
Effect Estimate
-13.00 [-18.49, -7.51]
-28.00 [-43.29, -12.71]
Not estimable
-2.10 [-3.58, -0.62]
43 GA versus Penile block
Outcome or Subgroup
43.1 HR (intra-operative)
43.2 Time to food intake
43.3 Time to rescure analgesia
43.4 Adverse events
Studies
1
1
1
1
Participants
60
60
60
60
Statistical Method
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
7.01 [4.56, 9.46]
13.50 [-5.48, 32.48]
-275.00 [-384.10, -165.90]
9.00 [0.51, 160.17]
44 Pudendal nerve block versus penile block
Outcome or Subgroup
44.1 Pain
44.2 Additional Analgesia
44.3 HR
44.4 Adverse events
Studies
2
2
2
1
Participants
138
138
138
60
Statistical Method
Std. Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Effect Estimate
-1.82 [-4.18, 0.54]
0.59 [0.00, 188.56]
6.35 [-6.96, 19.67]
0.20 [0.01, 4.00]
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
45 ultrasound-guided DPNB versus landmark-guided DPNB
Outcome or Subgroup
45.1 Pain
45.2 Adverse events
45.3 Resucures analgesia
Studies
1
1
1
Participants
310
310
310
Statistical Method
Mean Difference (IV, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
18-Dec-2019
Effect Estimate
0.20 [0.14, 0.26]
Not estimable
1.34 [0.96, 1.88]
Figures
Figure 1 (Analysis 1.1)
Forest plot of comparison: 1 DPNB versus no treatment or sham, outcome: 1.1 Pain score.
Figure 2 (Analysis 1.2)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
Forest plot of comparison: 1 DPNB versus no treatment or sham, outcome: 1.2 Cry time (by unit).
18-Dec-2019
Figure 3 (Analysis 1.3)
Forest plot of comparison: 1 DPNB versus no treatment or sham, outcome: 1.3 Heart rate (by unit).
Figure 4 (Analysis 1.6)
Forest plot of comparison: 1 DPNB versus no treatment or sham, outcome: 1.6 Oxygen saturation (by unit).
Figure 5 (Analysis 1.8)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 1 DPNB versus no treatment or sham, outcome: 1.8 Respiratory rate (by unit).
Figure 6 (Analysis 1.9)
Forest plot of comparison: 1 DPNB versus no treatment or sham, outcome: 1.9 Systolic blood pressure (by unit).
Figure 7 (Analysis 1.10)
Forest plot of comparison: 1 DPNB versus no treatment or sham, outcome: 1.10 Serum cortisol (nmol/dL) 30 min post.
Review Manager 5.3
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
Figure 8 (Analysis 2.1)
18-Dec-2019
Forest plot of comparison: 2 Ring block versus no treatment, outcome: 2.1 Cry time (by unit).
Figure 9 (Analysis 2.2)
Forest plot of comparison: 2 Ring block versus no treatment, outcome: 2.2 Heart rate (bpm) change-from-baseline.
Figure 10 (Analysis 2.3)
Forest plot of comparison: 2 Ring block versus no treatment, outcome: 2.3 Oxygen saturation (%) change-from-baseline.
Figure 11 (Analysis 2.4)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 2 Ring block versus no treatment, outcome: 2.4 Respiratory rate (rpm) change-from-baseline.
Figure 12 (Analysis 3.1)
Forest plot of comparison: 3 EMLA versus placebo or no treatment, outcome: 3.1 Pain score.
Figure 13 (Analysis 3.2)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
Forest plot of comparison: 3 EMLA versus placebo or no treatment, outcome: 3.2 Cry time (by unit).
18-Dec-2019
Figure 14 (Analysis 3.3)
Forest plot of comparison: 3 EMLA versus placebo or no treatment, outcome: 3.3 Heart rate (by unit).
Figure 15 (Analysis 3.4)
Forest plot of comparison: 3 EMLA versus placebo or no treatment, outcome: 3.4 Oxygen saturation (%).
Figure 16 (Analysis 3.5)
Forest plot of comparison: 3 EMLA versus placebo or no treatment, outcome: 3.5 Respiratory rate (rpm).
Figure 17 (Analysis 3.6)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0064.png
Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 3 EMLA versus placebo or no treatment, outcome: 3.6 Systolic blood pressure (mmHg) change-from-baseline.
Figure 18 (Analysis 3.7)
Forest plot of comparison: 3 EMLA versus placebo or no treatment, outcome: 3.7 Diastolic blood pressure (mmHg) change-from-baseline.
Figure 19 (Analysis 4.1)
Forest plot of comparison: 4 Topical lidocaine versus placebo, outcome: 4.1 Pain score.
Figure 20 (Analysis 4.2)
Forest plot of comparison: 4 Topical lidocaine versus placebo, outcome: 4.2 Cry time (s).
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
Figure 21 (Analysis 4.3)
18-Dec-2019
Forest plot of comparison: 4 Topical lidocaine versus placebo, outcome: 4.3 Heart rate (bpm).
Figure 22 (Analysis 4.5)
Forest plot of comparison: 4 Topical lidocaine versus placebo, outcome: 4.5 Respiratory rate (rpm).
Figure 23 (Analysis 5.1)
Forest plot of comparison: 5 Sucrose versus water or no treatment, outcome: 5.1 Pain score.
Figure 24 (Analysis 5.2)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 5 Sucrose versus water or no treatment, outcome: 5.2 Cry time (by unit).
Figure 25 (Analysis 5.4)
Forest plot of comparison: 5 Sucrose versus water or no treatment, outcome: 5.4 Oxygen saturation (by unit).
Figure 26 (Analysis 6.1)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 6 Acetaminophen versus placebo, outcome: 6.1 Pain / behavior score.
Figure 27 (Analysis 6.2)
Forest plot of comparison: 6 Acetaminophen versus placebo, outcome: 6.2 Cry time (%).
Figure 28 (Analysis 6.3)
Forest plot of comparison: 6 Acetaminophen versus placebo, outcome: 6.3 Heart rate (bpm).
Figure 29 (Analysis 6.4)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 6 Acetaminophen versus placebo, outcome: 6.4 Respiratory rate (rpm).
Figure 30 (Analysis 7.1)
Forest plot of comparison: 7 DPNB versus EMLA, outcome: 7.1 Pain score.
Figure 31 (Analysis 7.2)
Forest plot of comparison: 7 DPNB versus EMLA, outcome: 7.2 Cry time (%).
Figure 32 (Analysis 7.3)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 7 DPNB versus EMLA, outcome: 7.3 Heart rate (by unit).
Figure 33 (Analysis 7.5)
Forest plot of comparison: 7 DPNB versus EMLA, outcome: 7.5 Respiratory rate (rpm).
Figure 34 (Analysis 9.1)
Forest plot of comparison: 9 DPNB versus ring block, outcome: 9.1 Cry time (%).
Figure 35 (Analysis 9.2)
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
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Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 9 DPNB versus ring block, outcome: 9.2 Heart rate (bpm) change-from-baseline.
Figure 36 (Analysis 17.1)
Forest plot of comparison: 17 Caudal analgesia versus parenteral analgesia, outcome: 17.1 Need for analgesia.
Figure 37 (Analysis 17.2)
Forest plot of comparison: 17 Caudal analgesia versus parenteral analgesia, outcome: 17.2 Nausea or vomiting.
Figure 38 (Analysis 19.1)
Review Manager 5.3
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0071.png
Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 19 Caudal analgesia versus rectal or intravenous, outcome: 19.1 Need for any analgesia (rescue or other).
Figure 39 (Analysis 19.3)
Forest plot of comparison: 19 Caudal analgesia versus rectal or intravenous, outcome: 19.3 Other analgesia.
Figure 40 (Analysis 19.4)
Review Manager 5.3
71
B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0072.png
Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 19 Caudal analgesia versus rectal or intravenous, outcome: 19.4 Complications.
Figure 41 (Analysis 20.1)
Forest plot of comparison: 20 Caudal analgesia versus dorsal nerve penile block, outcome: 20.1 Need for any analgesia (rescue or other).
Figure 43 (Analysis 20.6)
Review Manager 5.3
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0073.png
Omskæring - PICO 2 Anæstesi
18-Dec-2019
Review Manager 5.3
73
B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0074.png
Omskæring - PICO 2 Anæstesi
18-Dec-2019
Forest plot of comparison: 20 Caudal analgesia versus dorsal nerve penile block, outcome: 20.6 Complications.
Figure 44 (Analysis 38.3)
Forest plot of comparison: 38 EMLA+sucrose+DPNB vs EMLA+sucrose+RB, outcome: 38.3 Heart rate.
Figure 45 (Analysis 38.5)
Forest plot of comparison: 38 EMLA+sucrose+DPNB vs EMLA+sucrose+RB, outcome: 38.5 Oxygen saturation %.
Review Manager 5.3
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B 7 - 2020-21 - Endeligt svar på spørgsmål 18: Spm. om udarbejdelse af en udtømmende oversigt over nyeste viden og forskningsresultater om omskæring af raske drenge offentliggjort i perioden 2000 og frem til d.d., til justitsministeren
2317998_0075.png
Omskæring - PICO 2 Anæstesi
Figure 46 (Analysis 38.8)
18-Dec-2019
Forest plot of comparison: 38 EMLA+sucrose+DPNB vs EMLA+sucrose+RB, outcome: 38.8 Pain.
Figure 47 (Analysis 43.1)
Forest plot of comparison: 43 GA versus Penile block, outcome: 43.1 HR (intra-operative).
Figure 48 (Analysis 43.2)
Forest plot of comparison: 43 GA versus Penile block, outcome: 43.2 Time to food intake.
Figure 49 (Analysis 43.3)
Forest plot of comparison: 43 GA versus Penile block, outcome: 43.3 Time to rescure analgesia.
Review Manager 5.3
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