Behotas 1992

Methods	Multi‐arm RCT ‐ 3 groups.
Participants	Women whose post‐episiotomy pain warranted analgesia, in Hospital ‘Sainte‐Antonie’, Paris. Participants were followed up on day‐1 postpartum. Women with hepatic or renal malfunction, a previous duodenal ulcer and those whose condition contra‐indicated treatment with NSAIDs, were excluded.
Interventions	Intervention: ibuprofen 400 mg (N = 31). Comparison: paracetamol 1 g (N = 28) and placebo (N = 31).
Outcomes	Pain intensity measured by VAS before, 30 minutes and thereafter hourly up to 6 hours (0 = no pain to 100 = worst possible pain); verbal scale at hour 0, hour 1 and hour 6 (0 = no pain to 5 = worst possible pain). Degree of improvement in response to treatment (0 = no improvement to 4 = greatly improved). 4‐ and 6‐hourly pain data were only available for ibuprofen and not for the comparator treatments. Need for additional analgesia data (6 hours) were the only outcome data available for inclusion in the review.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated.
Allocation concealment (selection bias)	Unclear risk	Identical white containers only – insufficient information as to whether these were sequentially numbered and sealed.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No clear statement.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data provided for all 90 participants (0% attrition rate in all groups).
Selective reporting (reporting bias)	Low risk	Pre‐specified outcomes were all reported.
Other bias	Low risk	Participants were similar in terms of geographical background, socio‐professional status and their overall clinical picture.