Methods | Multi‐arm RCT – 4 groups. | |
Participants | Postpartum women at least 18 years old who had undergone episiotomy and had at least moderate intensity pain at Tulane Univeristy School of Medicine and Clinical Research Centre, New Orleans. Women who received analgesics or tranquillisers within at least 4 hours of study entry, intended to breastfeed, had a history of convulsive disorders, known peptic ulcer, renal, hepatic or haematological disease or known allergic reactions to NSAIDs, were excluded. |
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Interventions | Intervention: aspirin 600 mg (N = 30); indoprofen 50 mg (N = 30); indoprofen 100 mg (N = 30). Comparison: placebo (N = 30). |
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Outcomes |
Pain assessed at baseline, 30 minutes after and thereafter through to 5 hours. 5‐hour data were used in the review (considered within 6‐hour time‐frame data). |
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Notes | Only aspirin included in the review since indoprofen was withdrawn from the market. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear statement on method used. |
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 | Data provided for all 120 participants (0% attrition rate in all groups). |
Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes were all reported. |
Other bias | Low risk | Demographic data indicated groups were similar in terms of age, race, height, weight and initial pain intensity. |