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 |