Methods | RCT | |
Participants |
Setting: Department of Obstetrics and Gynaecology, Washington University, St Louis, Missouri, USA (assumed from affiliation) Inclusion criteria: women, suffering moderate or severe pain following episiotomy Exclusion criteria: current or recent history of gastrointestinal bleeding; peptic ulcer; other GI disorders; alcohol or drug abuse; disorders of the nervous system, kidney, heart or blood; known allergies to aspirin or aspirin‐like analgesics; conditions likely to interfere with absorption, distribution, metabolism, or excretion of drugs; other pain requiring narcotic analgesics; acute dermatitis or other skin lesions; past or present malignancies; taking corticosteroids or other NSAIDs, anticoagulants or other drugs that may interfere with study medication; experiencing pain due to other causes; breastfeeding |
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Interventions |
Aspirin (N = 39 randomised) 650 mg aspirin Placebo (N = 40 randomised) All women: women received the study medication at the onset or recurrence of moderate or severe pain at least 16 but not more than 48 hours following induction of anaesthesia |
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Outcomes |
Adequate pain relief as reported by the woman: pain intensity and relief at 0.5 hours, then hourly for 8 hours was measured.
Maternal adverse effects: patient complaints were reported |
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Notes |
Funding: not reported Declarations of interests: not reported Additional arms: this was a 4‐arm trial also assessed etodolac 25 mg (N = 40)and 100 mg (N = 40); we have 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: "were randomly assigned" |
Allocation concealment (selection bias) | Unclear risk | Not detailed |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as "double‐blind" but no description of whether the study medications were identical in appearance, taste, etc |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not detailed |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No losses/exclusions reported, but %/no of women ‘remaining in study’ at 4, 6 and 8 hours reported |
Selective reporting (reporting bias) | Unclear risk | No access to trial registration or protocol to further assess selective reporting |
Other bias | Unclear risk | Results report patients were "well matched" for a variety of baseline characteristics, but no table of these characteristics presented |