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. 2016 Jul 15;2016(7):CD001069. doi: 10.1002/14651858.CD001069.pub5

Biran 2011.

Methods RCT
Painful intervention: venipuncture
Study location: NICUs at Hôpital Armand Trousseau, Paris, France and Centre Hospitalier de Meaux, Meaux, France
Study period: July to September 2007
Participants 76 preterm infants, mean (SD) PMA: sucrose group (n = 37): 32.6 (2.33) weeks; sucrose + EMLA group: (n = 39): 32.3 (2.01) weeks
Interventions Sucrose group: 0.5 mL 30% sucrose solution orally and placebo cream
Sucrose + EMLA group: 0.5 mL 30% sucrose solution orally and EMLA cream on the skin
Outcomes DAN scale, PIPP score
Notes Discussed adverse effects observed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization done in advance in blocks of 8 using a random number table
Allocation concealment (selection bias) Low risk Used opaque, sealed and sequentially numbered envelopes
Blinding (performance bias and detection bias) 
 All outcomes Low risk Participants and personnel blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes not reported for 4 infants because of problems with video recording
Selective reporting (reporting bias) Unclear risk The study protocol was not available to us so we could not judge whether there were any deviations from it
Other bias Low risk Appears free of other bias