De Vroey 1978.
Study characteristics | ||
Methods | Multi‐arm RCT ‐ 5 groups | |
Participants | Primiparous women aged between 16 ‐ 40 years who had a medio‐lateral episiotomy during the course of an otherwise uncomplicated delivery; delivery within previous 48 hours and complained of moderate to severe pain Department of Obstetrics and Gynaecology of the St. Christiana Clinic, Belgium |
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Interventions | Intervention: diflunisal 125 mg (N = 30); diflunisal 250 mg (N = 30); diflunisal 500 mg (N = 30) and aspirin 600 mg (N = 32) Comparison: placebo (N = 31) |
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Outcomes |
Pain severity was assessed before drug administration and then at hourly intervals up to 6 ‐ 8 hours; 4‐ and 6‐hour data available and extracted separately |
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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 | 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 | Clear information, including reasons, were provided on 5 exclusions after randomisation and on 3 withdrawals (9%) of the 32 women in the aspirin 600 mg group after treatment. (The attrition rate was 0% for all other groups) |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported |
Other bias | Low risk | None obvious; all women were primiparas with equal distribution across groups, based on initial severity of pain |