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 |
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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 |
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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 |