Honorato 1990.

Study characteristics
Methods	Multi‐arm RCT – 4 groups
Participants	Women aged 18 ‐ 35 years with intense post‐episiotomy pain requiring analgesia 3 centres; Navarre Teaching Hospital, Pamplona, Spain; Legnano Civil Hospital, Legnano, Italy, and Montebelluna Civil Hospital, Montebelluna, Spain Women suffering little or no pain, who had peptic ulcer, serious liver or kidney failure, puerperal fever or any complication within the puerperium or any serious general disease that could interfere with the results and were already being treated with NSAID agents or systemic steroids, tranquillisers, sedatives, narcotics and/or local anaesthetics, were excluded Participants were not allowed to take any other drug that might interfere with the results
Interventions	Intervention: aceclofenac 50 mg (N = 18); aceclofenac 100 mg (N = 24) and aceclofenac 150 mg (N = 21) Comparison: placebo (N = 13)
Outcomes	Pain intensity (4‐point scale of 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain, and VAS 0 (no pain) to 100 (worst possible pain)) Overall evaluation (1 = good, 2 = fair, 3 = nil and 4 = worse) Drug‐related adverse effects (1 = good, 2 = fair, 3 = poor) Degree of pain was measured at baseline, 30 minutes after and hourly thereafter up to 6 hours
Notes	Dates of study: NR Funding sources: NR Declarations of interest: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No clear statement on method used
Allocation concealment (selection bias)	Unclear risk	Suggests only that treatments were prepared so that neither the participant nor the investigator could distinguish between the doses
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	Loss of blood sample data in 18 of 45 participants of the 4 groups (not specified which groups); reasons provided. However, this outcome (serum concentration of aceclofenac) was not included in this review. 0% attrition rate for outcomes included in this review
Selective reporting (reporting bias)	Low risk	Results for the outcome 'Overall evaluation' are not provided, but important pain outcome data were all reported
Other bias	Unclear risk	No clear statement on balanced between‐group characteristics; also fewer numbers in placebo group