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. 2020 Jul 24;2020(7):CD012129. doi: 10.1002/14651858.CD012129.pub3

Mukherjee 1980.

Study characteristics
Methods RCT
Participants Setting: LNJP Hospital, New Delhi, India (assumed from author affiliation)
Trial dates: not reported (published in 1980)
Inclusion criteria: women from an otherwise healthy population whose chief complaint was moderate to severe pain following episiotomy on the first postoperative morning
Exclusion criteria: known hypersensitivity to dipyrone and aspirin; receipt of any analgesics 8 hours before entry to the study
Interventions Aspirin (N = 90 randomised)
500 mg aspirin; single oral dose in identical tablet form
Placebo(N = 88 randomised)
Placebo; single oral dose in identical tablet form
All women: nothing was permitted to be taken orally for the first hour after treatment administration
Outcomes Adequate pain relief as reported by the woman:
  • A research worker interviewed women at 0.5 hours, and hourly for 6 hours. Women were asked "By how many paise in the rupee is your pain less?"; pain relief was arbitrarily equated as 25% = slight (given a score of 1), 50% = moderate (given a score of 2), 75% = marked (given a score of 3), and 100% = complete (given a score of 4). Mean pain relief scores from 0 to 6 hours were provided in Figure 2, and were used to calculate TOTPAR scores, and to calculate 'Adequate pain relief as reported by the woman' (taken over 6 hours)

  • More than 50% pain relief was also reported


Maternal adverse effects: adverse drug reactions
Notes Funding: not reported
Declarations of interests: not reported
Additional arms: this 3‐arm trial also assessed dipyrone 500 mg (N = 89); we only included the relevant arms in this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "allocated at random"
Allocation concealment (selection bias) Unclear risk No details provided
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "approved double‐blind approach, which was strictly adhered to" "identical tablet form"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Reasonable to assume blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk No losses or exclusions
Selective reporting (reporting bias) Unclear risk No access to trial protocol to further assess risk selective reporting
Other bias Low risk Figures reported for baseline characteristics (such as pain severity, age, weight, and height at baseline), and reported "all three groups were also comparable…"