Bloomfield 1974.
Study characteristics | ||
Methods | Multi‐arm RCT – 4 groups. | |
Participants | An homogenous population of postpartum women with moderate to very severe episiotomy pain (mediolateral or midline incision) within 48 hours of an uncomplicated delivery at the University of Cincinnati Medical Centre; homogenous population of postpartum women Women who were unmarried, < 18 years old (but included if married and < 18 years), with history of aspirin allergy, given analgesics or sedatives, or other psychotropic drugs in the previous 6 hours, breastfeeding and with known drug dependence were excluded |
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Interventions | Intervention: ibuprofen 300 mg (N = 20); ibuprofen 900 mg (N = 20) and aspirin 900 mg (N = 20) Comparison: lactose placebo (N = 20). |
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Outcomes |
Only 6‐hour data available in extractable format |
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Notes | Dates of study: NR Funding sources: United States Public Health Service Grant HL‐05622 and The Upjohn Company 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) | Low risk | All treatments were in the form of film‐coated tablets identical in appearance and taste and pre‐packaged in coded number individual dose‐vials |
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 80 participants (0% attrition rate in all groups) |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were all reported |
Other bias | Unclear risk | Some baseline differences between group characteristics (e.g. weight higher in group receiving ibuprofen 900 mg and more unmarried in ibuprofen 300 mg group). Chance occurrences, but with an uncertain influence on the results |