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. 2017 Feb 9;2017(2):CD012129. doi: 10.1002/14651858.CD012129.pub2
Methods RCT
Participants Setting: Sinai Hospital of Baltimore, MD, USA (assumed from affiliation)
Inclusion criteria: women with no systemic medical illness, experiencing moderate to severe episiotomy pain within 48 hours following an otherwise uncomplicated vaginal birth
Exclusion criteria: "those used by Hermann et al"
Interventions Aspirin (N randomised was unclear; N = 40 analysed)
650 mg aspirin; single dose in identical capsules
Placebo (N randomised was unclear; N = 40 analysed)
Placebo; single dose in identical capsules
Outcomes Adequate pain relief as reported by the woman: one investigator assessed pain intensity and relief hourly for 6 hours;
  • Though SPID and TOTPAR scores were reported, the scales used to measure pain intensity and relief were not reported, and thus these data could not be used to calculate 'Adequate pain relief as reported by the woman'

  • Women's "overall impression" was reported (excellent, very good, good, fair and poor); excellent, very good and good ratings were used to calculate 'Adequate pain relief as reported by the woman' (taken at 6 hours)


Need for additional pain relief in the first 48 hours for perineal pain: frequency of re‐medication
Maternal adverse effects: women were observed hourly for adverse reactions
Notes Funding: "We would like to acknowledge the support of Sandoz, Inc. in this study"
Declarations of interests: not reported
Additional arms: this was a 4‐arm trial also assessed fluproquazone 100 mg (N = 41 analysed) and 200 mg (N = 39 analysed); we included only the relevant arms in this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned"
Allocation concealment (selection bias) Unclear risk No detail provided
Blinding of participants and personnel (performance bias) All outcomes Low risk Quotes: "double‐blind"… "All medication was supplied in identical capsules… packaged in individually sealed envelopes"
Blinding of outcome assessment (detection bias) All outcomes Low risk Considered reasonable to assume blinding
Incomplete outcome data (attrition bias) All outcomes Unclear risk In the whole trial, there were 166 who entered, and 160 provided "valid data for analyses"; other losses/exclusions not clearly reported
Selective reporting (reporting bias) Unclear risk No access to trial protocol to further assess; scales used to assess pain intensity and relief (needed to use SPID and TOTPAR scores to calculate adequate pain relief) were not reported
Other bias Unclear risk Baseline characteristics not reported