Sunshine 1983a

Methods	Multi‐arm RCT – 5 groups.
Participants	Women 18 years or older who were able to communicate meaningfully with the nurse observer and gave written consent and had moderate or severe post‐episiotomy pain after an uncomplicated birth and could tolerate oral medication at Hospital Maternidad Concepcion Palacios, Caracas, Venezuela. Women who were breastfeeding, had any complicating illness or abnormal postpartum bleeding, received any other investigational drug within 1 month prior to enrolment in the study or history of drug dependence or known allergic sensitivities to propionic acid derivatives and aspirin, were excluded.
Interventions	Intervention: aspirin 600 mg (N = 29); flurbiprofen 25 mg (N = 32); flurbiprofen 50 mg (N = 29) and flurbiprofen 100 mg (N = 31). Comparison: placebo (N = 31).
Outcomes	Pain intensity (0 = none, 1 = slight, 2 = moderate, 3 = severe). Pain relief (0 = none, 1 = a little (25%), 2 = some (50%), 3 = a lot (75%), 4 = complete (100%)). Adverse reactions (observed or volunteered). Additional medication (included if administered after 1st hour of study medication). Pain assessed prior to and hourly up to 6 hours after drug administration.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐program generated.
Allocation concealment (selection bias)	Unclear risk	States identical in appearance and packaging but insufficient information regarding sequentially numbered and sealed.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No clear statement.
Incomplete outcome data (attrition bias) All outcomes	Low risk	16 of 168 (10%) were dropped from the analysis because they received oxytocic medication (4 of 33 (12%) in the aspirin 600 mg group, 3 of 35 (9%) in the flurbiprofen 25 mg group, 5 of 34 (15%) in the flurbiprofen 50 mg group, 3 of 34 (9%) in the flurbiprofen 100 mg group, and 1 of 32 (3%) in the placebo group).
Selective reporting (reporting bias)	Low risk	Pre‐specified outcomes were all reported.
Other bias	Low risk	No significant differences between groups in terms of characteristics and clinical features; all had moderate or severe episiotomy pain on entry to the study.