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. 2016 Oct 7;2016(10):CD011219. doi: 10.1002/14651858.CD011219.pub3
Methods Randomised controlled trial
Participants Newborns of 36 weeks' PMA or more, more than 24 hours old and less than 30 days old, who needed blood tests for neonatal screening. Infants were born at Sanatorium Allende, Córdoba, Argentina, during November and December 2007
Interventions Oral glucose or oral paracetamol (n = 19) or oral placebo (n = 19) or EMLA to the heel (n = 19), or placebo to the heel (n = 19)
Outcomes Maximum NIPS and PIPP scores from the start of the heel lance to 3 minutes after the heel lance procedure
Notes We used Google translation to translate the article from Spanish to English
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
Allocation concealment (selection bias) Unclear risk No information was provided
Blinding of participants and personnel (performance bias) All outcomes Low risk A doctor was in charge of maintaining masking of the sample and knowing who administered treatment or placebo.
Acetaminophen was administered at 20 mg/kg (2 drops/kg) orally 60 minutes before the extraction. Matching placebo consisted of 2 drops/kg of distilled water given with a masked dropper. Corresponding placebo for EMLA was a moisturiser of similar appearance to EMLA
Blinding of outcome assessment (detection bias) All outcomes Low risk Pain assessment was performed independently by 2 observers (neonatal nurses) who used PIPP as the primary measure and NIPS as a secondary measure. Pain assessment began with the start of the puncture and ended after 3 minutes. Maximum scores achieved during these 3 minutes after the puncture were the outcome measures
Incomplete outcome data (attrition bias) All outcomes Low risk Outcomes were reported on all randomly assigned participants: 19 paracetamol + 19 placebo
Selective reporting (reporting bias) Unclear risk The protocol was not available to us, so we cannot judge whether selective reporting occurred
Other bias Low risk Study appears free of other bias