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. 2021 Jan 11;2021(1):CD011352. doi: 10.1002/14651858.CD011352.pub3

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
Interventions Intervention: ibuprofen 300 mg (N = 20); ibuprofen 900 mg (N = 20) and aspirin 900 mg (N = 20)
Comparison: lactose placebo (N = 20).
Outcomes
  • Changes in pain intensity (mean hourly PID scores, mean 6 hour summed PID scores)

  • Pain relief (pain reduction > 50%)

  • Side effects.


Only 6‐hour data available in extractable format
Notes Dates of study: NR
Funding sources: United States Public Health Service Grant HL‐05622 and The Upjohn Company
Declarations of interest: NR
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