van Lingen 2001.

Methods	Randomised controlled study undertaken during a 15‐month period at 2 hospitals in The Netherlands
Participants	Infants were eligible for the study if they fulfilled the following entry criteria: birth weight > 2500 grams, gestational age > 36 weeks, Apgar score at 5 minutes ≥ 7 and absence of congenital anomalies of the newborn. All infants were delivered by vacuum extraction. Infants admitted to the NICU for artificial ventilation because of respiratory insufficiency were excluded from the study. Furthermore, infants were excluded during the evaluation phase of the study if data were incomplete (e.g. in cases of early hospital discharge)
Interventions	Paracetamol suppositories 20 mg/kg (n = 61) or placebo suppositories (n = 61)
Outcomes	Modified 5 point facies scale at 1, 7, 13 and 19 hours after the first suppository had been given. Score of clinical condition
Notes	Dr van Lingen provided us with his PhD thesis — 'Pain Assessment and Analgesia in the Newborn: An Integrated Approach' — which includes a chapter on this trial
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation procedure was carried out by one of the hospital pharmacists, who had no knowledge of the clinical status of the neonates
Allocation concealment (selection bias)	Low risk	In the delivery room, separate numbered boxes were available for birth‐weight categories; each contained 4 suppositories with paracetamol suspended in Witepsol H‐15 as a fatty suppository base or a placebo with only a Witepsol H‐15 base
Blinding of participants and personnel (performance bias) All outcomes	Low risk	See allocation concealment
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Scoring was performed by nurses from the obstetric and paediatric wards, who were blinded to the group to which the infant was assigned
Incomplete outcome data (attrition bias) All outcomes	Low risk	18 infants were excluded as they failed to receive 3 or more doses of the study drug or placebo. 16 infants were discharged before all suppositories were given, and in 2 other infants, the study drug was stopped on parental request. 61 infants remained in each group; 59 in the paracetamol group and 60 in the placebo group underwent pain assessments
Selective reporting (reporting bias)	Unclear risk	The protocol for the study was not available to us; therefore we cannot judge whether selective reporting occurred
Other bias	Low risk	Study appears free of other bias

BW = birth weight (grams).

NIPS = Neonatal Infant Pain Score.

PIPPS = Premature Infant Pain Profile.

PMA = postmenstrual age (weeks).