Tinner 2013.
| Methods | Randomised double‐blind placebo‐controlled trial | |
| Participants | Singleton newborns, born by assisted vaginal delivery (forceps or vacuum), with PMA > 35 weeks and BW > 2000 grams. Infants were admitted to one of 3 Swiss university hospitals | |
| Interventions | Paracetamol suppositories (60/80/100 mg in infants < 3000 grams/3000 to 4000 grams/> 4000 grams birth weight) at 2 hours and 8 hours of life, or placebo suppositories at 2 hours and 8 hours of life | |
| Outcomes | Prolonged pain and discomfort during the first 24 hours of life were assessed by the Échelle de Douleur et d’Inconfort du Nouveau‐né (neonatal pain and discomfort) (EDIN) scale Assessments were carried out by nurses or midwives in charge at baseline (2 hours), and at 4, 8, 12 and 24 hours of life Acute pain response to a short painful stimulus 2 to 3 days after birth was assessed by the 7 behavioural items of the Bernese Pain Scale for Newborns (BPSN), validated to measure acute pain in newborn infants on a scale between 0 (no pain) and 21 (maximum pain). Infants received 0.2 mL sucrose solution 1 minute before heel lance performed to obtain blood for metabolic screening at 2 to 3 days of life. BPSN was scored by nurse immediately before and after the heel lance. In addition, infants were videotaped and tapes were scored off‐site by a single reviewer. Whether infants cried after heel lance and, if so, the time infants spent crying after heel lance, were recorded |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The Pharmacy Institute held the randomisation key with a block random allocation |
| Allocation concealment (selection bias) | Low risk | At 2 hours and 8 hours of life, infants received 2 coded suppositories that contained paracetamol or placebo. The sequence remained concealed until the study was completed |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind placebo‐controlled study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind placebo‐controlled study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All infants recruited were randomly assigned to receive placebo (n = 69) or paracetamol (n = 71), and all infants randomly assigned received the allocated intervention and continued treatment as planned (i.e. they received 2 suppositories at 2 hours and 8 hours of life). 17 subsequent drop‐outs (8 (3/5/0) infants transferred to the neonatal unit and 9 (0/2/7) infants who left the maternity hospital before metabolic screening). Thus, a total of 123 newborn infants completed the study; 62 had received paracetamol and 61 placebo |
| Selective reporting (reporting bias) | Low risk | The protocol is available at www.clinicaltrials.gov NCT 00488540; no deviations from the protocol are apparent |
| Other bias | Low risk | Study appears free of other bias |