Jain 1978b

Methods	RCT
Participants	Setting: Department of Medicine, Tulane University School of Medicine, USA (assumed from affiliation) Inclusion criteria: women with severe episiotomy pain or severe uterine cramping pain, following an uncomplicated vaginal birth Exclusion criteria: mild or moderate pain or baseline pain < 60% on a pain analogue; dependent on analgesics or tranquillisers; hypersensitive to salicylates or caffeine; gastrointestinal, hepatic, or renal history or a history of psychiatric illness; emotionally unstable or overtly anxious
Interventions	Aspirin (N = 16 randomised) 650 mg aspirin; single oral dose Placebo (N = 16 randomised) Placebo; single oral dose All women: duration between previous analgesic and test medication was at least 6 hours
Outcomes	Adequate pain relief as reported by the woman: a trained nurse observer rated pain intensity and relief hourly for 4 hours. Pain intensity: rated from 0 to 8 (0 = no pain; 2 = slight pain; 4 = moderate pain; 6 = severe pain; 8 = very severe pain) Pain relief: rated from 0 to 8 (0 = worse; 2 = unchanged; 4 = less than half gone; 6 = more than half gone; 8 = complete relief) Pain analogue: rated on visual analogue scale 0 = no pain; 100 = worst pain I have ever experienced Subjective measure of global performance at last interview: rated from 2 to 8 (2 = poor; 4 = fair; 6 = good; 8 = very good) The results were not reported in such a way to calculate 'Adequate pain relief as reported by the woman' Maternal adverse effects: women questioned about adverse effects at the last interview
Notes	Funding: "We wish to thank Mr. Garrett Swenson of American Home Products for the double‐blind supplies of test drug, and Dr. Ilbok lee (Ives Laboratories), Dr. Bruce Schneider (Wyeth Laboratories), and Dr. Syliva Wassertheil‐Smoller (Albert Einstein College of Medicine) for their assistance in the statistical analysis of data" Declarations of interest: not reported Additional arms: manuscript reports results of 2 randomised controlled trials; we have excluded the first, as it combined women with uterine and episiotomy pain, and did not report any results separately for the subset of women with episiotomy pain. The included trial was a 3‐arm trial also assessed 800 mg aspirin and 64 mg caffeine (N = 15); 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: "Patients were divided at random", no further detail provided
Allocation concealment (selection bias)	Unclear risk	No detail provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "double blind", no further detail provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not detailed
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Complete data has not been reported and published
Selective reporting (reporting bias)	High risk	No access to trial protocol; limited data presented, results reported incompletely in text
Other bias	Unclear risk	No baseline characteristics reported