Olson 1997.

Study characteristics
Methods	Multi‐arm RCT – 5 groups
Participants	Women 18 years or older and able to communicate meaningfully with the nurse‐observer, severe episiotomy pain after uncomplicated delivery, could tolerate oral medication and had no medications that might confound the results were permitted during the study or for the 4 hours before entry to the study Hospital Maternidad Concepcion Palacios, Caracas, Venezuela Women planning to breastfeed within 24 hours after administration of study medication, with serious complicating illness, abnormal postpartum bleeding, active peptic ulcer disease or other gastrointestinal disease associated with blood loss, who received any other investigational drug within 1 month before enrolment in study or with a history of drug or alcohol abuse or known allergic sensitivities to the study medications, were excluded
Interventions	Intervention: diclofenac 25 mg (N = 52); diclofenac 50 mg (N = 50); diclofenac 100 mg (N = 51) and aspirin 650 mg (N = 50) Comparison: placebo (N = 52)
Outcomes	Pain intensity (4‐point scale of 0 = none, 1 = slight, 2 = moderate and 3 = severe) Pain relief (0 = none, 1 = a little (25%), 2 = some (50%), 3 = a lot (75%) and 4 = complete (100%)) Adverse reactions (recorded if they were observed or volunteered) Overall improvement (7‐point scale from 1 = very much worse to 7 = very much better) Study medication global rating (0 = poor, 1 = fair, 2 = good and 3 = excellent) Pain intensity was measured prior to, 30 minutes after, and hourly thereafter up to 8 hours following drug administration. 4‐hour data used in the review (6‐hour data could not be extracted)
Notes	Dates of study: NR Funding sources: Ciba‐Geigy Corporation Declarations of interest: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random permutation
Allocation concealment (selection bias)	Unclear risk	Doses were identical in appearance and packaging but no indication if 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	Data provided for all 255 participants (0% attrition rate in all groups)
Selective reporting (reporting bias)	Low risk	All prespecified outcomes were reported
Other bias	Low risk	No significant differences between groups in terms of characteristics and clinical features; all had severe episiotomy pain on entry to the study