Sunshine 1983b

Methods	RCT
Participants	Setting: Hospital Maternidad Concepcion Palacios, Caracas, Venezuela Inclusion criteria: women with moderate or severe post‐episiotomy pain after an uncomplicated delivery, who could tolerate oral medication, aged ≥ 18 years Exclusion criteria: breastfeeding; any complicating illness or abnormal postpartum bleeding; receipt of any other investigational drug within 1 month prior to enrolment; history of drug dependence or known allergic sensitivities to prolonic acid derivatives or aspirin
Interventions	Aspirin (N = 29 randomised) 600 mg aspirin; single oral dose of 5 identical tablets Placebo (N = 31 randomised) Placebo; single oral dose of 5 identical tablets All women: no medications that might confound the interpretation of the efficacy and/or adverse effect liability of the study analgesics were permitted concomitantly or during the 4 hours before taking the study medication
Outcomes	Adequate pain relief as reported by the woman: the same nurse‐observer interviewed the women at the time medication was administered and hourly for 6 hours: Women were asked to assess the intensity of their pain from 0 to 3 (0 = none; 1 = light pain; 3 = moderate pain; 3 = severe pain); SPID scores were reported and used to calculate 'Adequate pain relief as reported by the woman' (taken over 6 hours) Women were asked to classify their degree of pain relief from 0 to 4 (0 = none; 25% (1) = a little; 50% (2) = some; 75% (3) = a lot; 100% (3) = complete); total scores were also reported Need for additional pain relief in the first 48 hours for perineal pain: re‐medication within 6‐hour study period Maternal adverse effects: adverse reactions were noted if they were observed or volunteered
Notes	Funding: "Supported by a grant from Boots Pharmaceuticals, Inc" Declarations of interests: not reported Additional arms: this was a 5‐arm trial also assessed flurbiprofen 25 (N = 32), 50 (N = 29), 100 mg (N = 31); we included only the relevant arms in this review
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "In each successive block of ten patients a computer program generated a random permutation such that, two patient received each treatment"
Allocation concealment (selection bias)	Unclear risk	No detail provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "double‐blind… Each patient was given one dose of five tablets that were identical in appearance and packaging"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Same nurse interviewer interviewed patients at administration and hourly afterwards; reasonable to assume blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	If women reported inadequate pain relief before the first hour, a conventional analgesic agent was given and they were removed from the study; if women requested rescue medication after the first hour, they were given the conventional analgesic and included in the analyses – baseline pain intensity and zero pain relief were assumed for the duration of scheduled observations; 168 women were enrolled in the study; 16 were "dropped from the analysis because they received concomitant oxytoxic medication that the sponsor felt might confound the interpretation of the efficacy of the study drug" 1/32 in the placebo group; 4/33 in the aspirin group; no women re‐medicated in the first hour; 14 re‐medicated in placebo group; 1 re‐medicated in the aspirin group
Selective reporting (reporting bias)	Unclear risk	No access to trial protocol to further assess selective reporting
Other bias	Low risk	Baseline characteristics reported were balanced between groups; no other obvious risk of bias identified