Methods | Multi‐arm RCT – 4 group. | |
Participants | Women > 15 years with moderate to severe episiotomy pain after normal vaginal birth at Women’s Hospital, Los Angeles County. Women with a history of reaction or hypersensitivity to NSAID or salicylates, receiving perineal < 1 hour before entry to study, received analgesics, sedatives, psychotropic medications, or topical perineal anaesthetics within 4 hours of entering study or had an active disease that might interfere with the evaluation of study medications, were excluded. |
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Interventions | Intervention: meclofenamate 200 mg (N = 55); meclofenamate 100 mg (N = 55) and codeine 60 mg (N = 53). Comparison: placebo (N = 52). |
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Outcomes |
Pain measures were assessed at baseline prior to treatment, at 30 minutes after and hourly thereafter to 6 hours. |
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Notes | Codeine 60 mg not considered for the review as not an NSAID. | |
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 | The attrition rate was 0%, but 5 of 220 (2%) participants were excluded from efficacy analysis because of protocol violation. |
Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes were all reported. |
Other bias | Low risk | No differences in baseline characteristics. |