| 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 |
