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 |
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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 |
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Outcomes |
Adequate pain relief as reported by the woman:
Maternal adverse effects: adverse drug reactions |
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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 |
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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…" |