Methods | Parallel RCT ‐ 2 groups. | |
Participants | Women with mediolateral episiotomy without a third‐ or fourth‐degree tear after a normal uncomplicated delivery, at term, who had not used any analgesic drugs within 4 hours preceding the study at the King Chulalongkorn Memorial Hospital between June 2006 and November 2006. Women with an allergy to either study drug, a history of drug dependence, regular use of analgesic drugs before or during pregnancy, and any medical condition known to be potentially exacerbated by acetaminophen or NSAIDS, including a history of gastrointestinal ulcer or bleeding, significant renal or liver impairment and asthma, postpartum haemorrhage or any other major postpartum complications, were excluded. |
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Interventions | Intervention: ibuprofen 400 mg (N = 106). Comparison: acetaminophen 500 mg (N = 104). |
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Outcomes |
An initial pain rating was recorded before participants took the first dose of analgesia and at 1, 2, 3 and 4 hours after. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear statement on method used; states only "stratified random sampling technique". |
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 | Low risk | Outcome assessor blind to treatment group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data provided for all 210 participants (0% attrition rate in all groups). |
Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes were all reported. |
Other bias | Low risk | Treatment groups were similar in demographic data and clinical features; the severity of perineal pain did not differ between the groups before the treatment. |