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).