| Methods |
Randomised, double‐blind, controlled trial. Single‐centre study conducted at Women's College Hospital in Toronto, Ontario, Canada |
| Participants |
75 term neonates undergoing heel lance for screening for newborn disease |
| Interventions |
Oral paracetamol cherry elixir 20 mg/kg, 60 to 90 minutes before heel lance (n = 38), or placebo (cherry elixir) (n = 37) |
| Outcomes |
Per cent facial action – brow bulge, eye squeeze and nasolabial fold (range 0% to 300%); per cent of time spent crying (range 0% to 100%) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random numbers list |
| Allocation concealment (selection bias) |
Low risk |
Neonates were randomly assigned by the pharmacy department to receive before‐heel lance oral paracetamol cherry elixir (32 mg/mL) at a dose of 20 mg/kg or an equal volume of placebo (cherry elixir) of identical appearance |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
See allocation concealment |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
See allocation concealment |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
10 infants were excluded from the efficacy analysis. In 9 cases, infants had multiple heel lances (n = 5 in group 1; n = 4 in group 2); in 1 case (group 1), the video recording was of poor quality. Data for 13% of enrolled infants were missing |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol for the study was not available to us, so we cannot judge whether selective reporting occurred |
| Other bias |
Low risk |
Study appears free of other bias |
