Methods | Multi‐arm RCT – 3 groups. | |
Participants | Hospitalised women with moderate or severe episiotomy pain after normal uncomplicated birth, New York. Women with eclampsia or any other medical complication, allergic hypersensitivity to treatment drugs or had any analgesia or NSAID in 4 hours prior to study entry, were excluded. |
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Interventions | Intervention: ibuprofen 400 mg (N = 36). Comparison: placebo (N = 38) and acetaminophen 1000 mg (N = 37). |
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Outcomes |
Pain measured before medication, 30 minutes and 1‐4 hours after. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random code. |
Allocation concealment (selection bias) | Unclear risk | No clear statement. |
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 | 4 of 115 (3%) participants removed after randomisation due to re‐medicated but time not known and not specified from which group. |
Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes were all reported. |
Other bias | Low risk | The groups were similar in terms of demographics and clinical features. |