Badiee 2009

Methods	Prospective randomised double‐blind placebo‐controlled study
Participants	72 preterm neonates (≤ 34 weeks PMA, age ≥ 24 hours, no feeding for at least 30 minutes, Apgar scores > 3 at 5 minutes). 36 infants in each group. Infants were treated at the NICU of Alzahra University Hospital, Isfahan, Iran, during the period of April 2007 to August 2007
Interventions	The treatment group (n = 36) received oral paracetamol 40 mg/kg, and the placebo group (n = 36) received an equal volume of sterile water 90 minutes before heel lance
Outcomes	PIPP and crying time during the first 3 minutes of the procedure. Differences in SpO₂ and heart rate between baseline and the heel lancing period
Notes	Dr Badiee confirmed in an email on 5 January 2015 that the paracetamol solution looked the same as sterile water
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated block randomisation
Allocation concealment (selection bias)	Low risk	The research pharmacist randomly assigned newborns to treatment and placebo groups by computer‐generated block randomisation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The paracetamol oral solution looked similar to sterile water
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Neither the observers nor the nurse who carried out the heel lancing were aware of which treatment had been given to the neonate
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes were reported for all randomly assigned infants
Selective reporting (reporting bias)	Unclear risk	The protocol for the study was not available to us, so we cannot judge whether there were any deviations from the protocol
Other bias	Low risk	Study appears free of other bias