London 1983.
Study characteristics | ||
Methods | Multi‐arm RCT – 4 groups | |
Participants | Women between the ages of 18 and 40, no systemic medical illness and experienced moderate to severe episiotomy pain within 48 hours following an otherwise uncomplicated vaginal delivery Department of Obstetrics and Gynaecology, Sinai Hospital of Baltimore, USA Exclusion criteria were those used by Hermann et al 1980 and included; women with pain not due directly to the episiotomy (e.g. uterine cramps), except for cleansing, all wound care was suspended for the whole study period; patients who appeared unlikely to communicate meaningful information about their pain; women with only mild pain; those under 16 years of age; history of drug allergy; any relevant psychiatric, neurologic, cardiovascular, pulmonary, hepatic, gastrointestinal, or renal disorders and women given analgesics, sedatives, or other psychotropic drugs within 3 hours were excluded |
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Interventions | Intervention: fluproquazone 200 mg (N = 39); fluproquazone 100 mg (N = 41), and aspirin 650 mg (N = 40) Comparison: placebo (N = 40) |
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Outcomes |
Rating scale information for pain intensity and pain relief measures are not provided; unable to use formula to calculate adequate pain relief, but adequate pain relief could be derived from good to excellent overall impression rating |
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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 |
Allocation concealment (selection bias) | Unclear risk | States sealed envelopes, but unclear if consecutively‐numbered or opaque |
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 of the 166 participants, 160 were included in the analysis (4% excluded). Provides reasons for exclusions after entering study; the data of 6 patients were not included since they did not follow the assigned protocol. |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were all reported. |
Other bias | Unclear risk | No clear statement on baseline characteristics or balance across groups |