10. Trials assessing pain during circumcision.

Study	Participants	Procedure	Interventions	Outcomes	Metrics used	Results
Al Qahtani 2014	90 full‐term newborn males who underwent circumcision. PMA 38 weeks or more, 5‐min Apgar score of 8 or higher, PNA of 12 h or more, birthweight > 2500 g and free from jaundice, anomalies of the penis and analgesia or sedation in the previous 48 h	Circumcision	EMLA group (n = 30): 1 g of a topical mixture of lidocaine (2.5%) and prilocaine (2.5%) cream was applied to the shaft of the penis with an occlusive dressing 1 h before the procedure Sucrose group (n = 30): 2 mL oral sucrose (24% weight by volume) given through a dropper onto the tongue 2 min before the procedure EMLA + sucrose group (n = 30): infants given both EMLA cream and oral sucrose as above	N‐PASS used to assess the severity of pain and neonatal response to pain, 5 min before, during and 5 min after the circumcision for all newborns. The scale measures both physiologic (HR, RR, blood pressure and oxygen saturation) and behavioural (crying irritability, behaviour state, facial expression and extremities tone) responses to pain	Mean, SD (Abstract says median) (Tables state mean and SD)	N‐PASS scores were significantly lower in EMLA + sucrose group (median EMLA + sucrose group = 5.2, EMLA group = 5.8, sucrose group = 8.5; P < 0.001). The endogenous response to pain in terms of escalation of heart rate and reduction in O2 saturation were minimal among EMLA + sucrose group (P < 0.0001) Duration of crying was comparable among all the groups Data used in RevMan‐analyses
Herschel 1998	120 healthy male newborns, ≥ 38 weeks PMA	Circumcision	Control group (n = 40): no treatment DPNB group (n = 40): 0.8 mL 1% lidocaine without epinephrine injected into dorsolateral penile root 3 min before procedure Sucrose group (n = 39): pacifier dipped in 50% sucrose with a gauze pad moistened with sucrose inside the nipple 2 min before procedure	HR at baseline, restraint, skin preparation for procedure, lateral clamping, lysis of adhesions, dorsal clamping, dorsal cut, retraction, application of Gomco bell and clamp, tightening of clamp, excision of foreskin, removal of clamp, removal of bell, placement of dressing and overall change in HR from baseline SpO2 at baseline and throughout procedure; change from baseline during the circumcision procedure	Mean, SD, mean differences and 95% CI	Mean change in HR from baseline through all follow‐up times were significantly different between groups (P < 0.001) Mean (95% CIs) HR differences: control vs. DPNB: 27.1 beats/min (17.6 to 36.6) control vs. sucrose: 9.7 beats/min (0.1 to 19.3) sucrose vs. DPNB: 17.4 beats/min (7.8 to 27.0) Sucrose had a statistically significant effect compared to the no treatment controls (P < 0.001) Significant differences between groups in changes in SpO2 from baseline to circumcision (P < 0.001) Mean (95% CI) SpO2 differences between the 3 groups from baseline: Control: ‐2.5 (‐15.8 to 3.12) DPNB: ‐0.8 (‐4.3 to 5.5) Sucrose: 0.7 (‐6.8 to 12.5) Differences between both the DPNB and sucrose groups compared to control were significant (P < 0.05) Control vs. sucrose: ‐3.3 (‐5.0 to ‐1.6) was statistically significant (P < 0.001) Data used in RevMan‐analyses
Kaufman 2002	57 term infants, mean age at time of procedure 30 h to 43 h	Circumcision	Gomco + water group (n = 14): Gomco method (of circumcision) and pacifier dipped in water Gomco + sucrose group (n = 14): Gomco method and pacifier dipped in 24% sucrose Mogen + water group (n = 15): Mogen method (of circumcision) and pacifier dipped in water Mogen + sucrose group (n = 14): Mogen method and pacifier dipped in 24% sucrose All infants had EMLA cream applied 1 to 3 h before procedure	Time spent crying during procedure Time spent grimacing Procedure stages: Table to restraint Restraint to forceps Forceps to excision Excision to unrestraint Unrestraint to end	Median and means, graphically Not reported	Cumulative mean time crying for forceps to unrestraint interval in the Gomco + sucrose group was 56 s (median = 53 s) compared to 86 s (median = 78 s) in the Gomco + water group (P = 0.0001) Crying time in Mogen + sucrose and Mogen + water groups were not significantly different Overall, mean crying time significantly decreased in infants treated with sucrose compared to infants treated with water (P = 0.0001) Significantly less time spent grimacing in the Gomco + sucrose group compared to the Gomco + water group (P = 0.0001) No significant differences between Mogen + sucrose and the Mogen + water groups Overall, mean time grimacing was significantly reduced in infants treated with sucrose compared to infants treated with water (P = 0.0001) No data were presented that could be used in RevMan‐analyses
Stang 1997	80 healthy, term, newborn male infants, mean PMA 39.5 weeks	Circumcision	DPNB + NNS group (n = 20): 0.8 mL lidocaine and 0.2 mL saline plus pacifier dipped in water and using new padded restraint chair Buffered DPNB + NNS group (n = 20): 0.8 mL lidocaine and 0.2 mL sodium bicarbonate and pacifier dipped in water DPNB + sucrose group (n = 20): 0. 8 mL lidocaine and 0.2 mL saline and pacifier dipped in 24% sucrose Control group (n = 20): DPNB (0.8 mL lidocaine and 0.2 mL saline) and pacifier dipped in water, rigid chair	Plasma cortisol level 30 min after beginning circumcision Behavioural arousal and behavioural distress scores were recorded at five scoring periods: baseline injection immediate post injection (2 min) delayed post injection (the next 2 min) circumcision	Mean, SD	Plasma cortisol levels not significantly different between groups Data used in RevMan‐analyses

Abbreviations

CI = confidence interval
 DPNB = dorsal penile nerve block
 EMLA = eutectic mixture of local anaesthetics
 HR = heart rate
 N‐PASS = Neonatal Pain Agitation and Sedation Scale

PMA = Post menstrual age
 PNA = postnatal age
 RR = respiratory rate
 SD = standard deviation
 SpO₂ = oxygen saturation