Sunshine 1983a

Methods	RCT
Participants	Setting: Hospital Maternidad Concepcion Palacios, Caracas, Venezuela Inclusion criteria: women with severe post‐episiotomy pain after an uncomplicated birth; aged ≥18 years, who could tolerate oral medications Exclusion criteria: known allergic sensitivities to study medication; abnormal postpartum bleeding, or complicating illnesses; breastfeeding; history of drug dependence; receipt of other investigational drugs prior to enrolment
Interventions	Aspirin (N = 30 randomised) 600 mg aspirin; single oral dose of 1 aspirin capsule and 1 placebo tablet Placebo (N = 30 randomised) Placebo; single oral dose of 1 capsule and 1 tablet All women: as a single dose; women were given the study medication by the nurse observer when their pain was severe; no medications that might alter the response to the study analgesics were permitted concomitantly or during the 4 hours before the test medication was taken
Outcomes	Adequate pain relief as reported by the woman: the same nurse observer interviewed at the time of medication, 0.5 hours, and hourly for 4 hours Women were asked to classify the intensity of their pain on a scale of 0 to 3 (0 = none; 1 = slight 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 4 hours) Women were asked to estimate their percentage of pain relief from 0 to 4 (0 = none; 25% = 1; 50% = 2; 75%= 3; 100% = 4); total scores were also reported Women also were asked to estimate the time to onset of effect; to rate their overall improvement on a 7 point scale (1 = very much worse; 2 = much worse; 3 = a little worse; 4 = no change; 5 = a little better; 6 = much better; 7 = very much better); and to rate the study medication on a 4 point scale (0 = poor; 1 = fair; 2 = good; 3 = excellent) Need for additional pain relief in the first 48 hours for perineal pain: re‐medication within 4 hours Maternal adverse effects: adverse reactions were noted if observed or volunteered
Notes	Funding: "A grant‐in‐aid and test medication from Upjohn Company made this research possible" Declarations of interests: not reported Additional arms: this was a 4‐arm trial also assessed zomepirac 100 mg (N = 30) and ibuprofen 400 mg (N = 30); we have 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: "In a randomised study"
Allocation concealment (selection bias)	Unclear risk	No detail provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "in a double‐blind fashion. Because the study medications were not identical in appearance, a double‐dummy technique was used"; each woman received one tablet and one capsule as appropriate
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The same nurse observer interviewed the patients
Incomplete outcome data (attrition bias) All outcomes	High risk	If before the first hour a woman reported inadequate pain relief, a conventional analgesic was given and she was removed from the study; if a woman requested ‘rescue’ medication after the first hour she was given it and was included in the evaluation; responses at the time of re‐medication were assumed for the duration of the study; all 120 women who participated in the study were included in the analysis; 5 women who received placebo required rescue medication during the study; no women receiving aspirin required re‐medication
Selective reporting (reporting bias)	High risk	Some incomplete reporting "The three drugs were much the same for mean onset, duration and time to peak values. The hypothesis that there is no difference among treatments was rejected at the 0.05 level or better for all variables"; patients rating of overall improvement and of study medication mentioned in methods and not reported
Other bias	Low risk	Baseline characteristics presented were comparable between groups; no other obvious sources of bias identified