Jain 1985.

Study characteristics
Methods	RCT
Participants	Setting: Tulane University School of Medicine, New Orleans, Louisiana, USA (assumed from affiliation) Trial dates: not reported (published in 1985) Inclusion criteria: postpartum women who had undergone episiotomy and requested analgesic medication for pain of at least moderate intensity, aged ≥ 18 years Exclusion criteria: receipt of analgesics or tranquillisers within 4 hours of stud entry; planned to breast feed; history of convulsive disorders, known peptic ulcer, renal, hepatic or haematological disease; known allergic reactions to salicylates or other NSAIDs
Interventions	Aspirin (N = 30 randomised) 600 mg aspirin; single dose of 2 matching capsules Placebo (N = 30 randomised) Placebo; single dose of 2 matching capsules All women: the test drug was given in a single dose in the form of 2 matching capsules.
Outcomes	Adequate pain relief as reported by the woman: a trained nurse observed recorded pain intensity and relief at 0.5 hours and hourly to 5 hours Pain intensity was rated from 0 to 3 (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain); SPID scores were reported and used to calculate 'Adequate pain relief as reported by the woman' (taken over 5 hours) Pain relief was rated from 0 to 4 (none; 1 = a little; 2 = some; 3 = a lot; 4 = complete); TOTPAR scores were also reported Women's overall rating of the medication's efficacy was also reported, rated from 0 to 3 (0 = poor; 1 = fair; 2 = good; 3 = excellent) Need for additional pain relief in the first 48 hours for perineal pain: need for supplemental analgesia in 5‐hour study period Maternal adverse effects: adverse effects reported by women or observed by the nurse were recorded
Notes	Funding sources: "Supported in part by a grant from Adria Laboratories, inc., Columbus, Ohio" Declarations of interests: not reported Additional arms: this 4‐arm trial also assessed indoprofen 50 (N = 30) and 100 mg (N = 30); 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"; no further details provided
Allocation concealment (selection bias)	Unclear risk	No details provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quotes: "double blind" "the test drug was given in a single dose in the form of two matching capsules"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not specifically stated; reasonable to assume women and the nurse were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Any patients who experienced inadequate pain relief were permitted to remedicate with an alternate analgesic. In such cases pain evaluations were discontinued and for the balance of the study, patients were assigned a pain intensity score equal to that at the time of remedication and pain relief scores of zero" … There were however, no women who required re‐medication
Selective reporting (reporting bias)	Unclear risk	No access to trial registration or protocol to further assess selective reporting
Other bias	Low risk	Baseline characteristics comparable between groups; no other obvious sources of bias identified