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

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
Interventions Intervention: fluproquazone 200 mg (N = 39); fluproquazone 100 mg (N = 41), and aspirin 650 mg (N = 40)
Comparison: placebo (N = 40)
Outcomes
  • Pain intensity (SPID)

  • Pain relief (TOTPAR)

  • Adverse reactions

  • Overall impression (poor, fair, good, very good, excellent).


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
Notes Dates of study: NR
Funding sources: NR
Declarations of interest: NR
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