Behotas 1992.
Study characteristics | ||
Methods | Multi‐arm RCT ‐ 3 groups | |
Participants | Women whose post‐episiotomy pain warranted analgesia 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 |
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Interventions | Intervention: ibuprofen 400 mg (N = 31) Comparison: paracetamol 1 g (N = 28) and placebo (N = 31) |
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Outcomes |
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 |
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Notes | Dates of study: NR Funding sources: NR Declarations of interest: NR |
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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 | Prespecified outcomes were all reported |
Other bias | Low risk | Participants were similar in terms of geographical background, socio‐professional status and their overall clinical picture |