Yscla 1988

Methods	Parallel RCT – 2 groups.
Participants	Only women those with severe episiotomy pain aged 18‐39 years in the 48 hours following an uncomplicated delivery at Mollet General Hospital, Barcelona. Women with slight or moderate pain, gastroduodenal disorders, and liver or kidney failure, a known history of hypersensitivity to phynylacetic acid derivatives or to acetylsalicylic acid and similar substances, treated with NSAIDs or systemic steroids or exceeding the age limits and who did not give consent, were excluded.
Interventions	Intervention: aceclofenac 100 mg (N = 20). Comparison: placebo (N = 20).
Outcomes	Pain intensity (0 = no pain, 1 = mild, 2 = moderate and 3 = severe pain). Pain relief (> 50% reduction). Possible side effects. Overall evaluation. Pain intensity was measured before treatment, 30 minutes and 1 hourly to 6 hours thereafter, but these data could not be extracted.
Notes
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	Packaged in identical packs identifiable only by the letters A and B; but does not state 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 40 participants (0% attrition rate in all groups).
Selective reporting (reporting bias)	Low risk	Pre‐specified outcomes were all reported.
Other bias	Low risk	Groups similar at baseline.

ASA: acetylsalicylic acid NSAID: non‐steroidal anti‐inflammatory drug RCT: randomised controlled trial SPID: Summed Pain Intensity Difference TOTPAR: Total Pain Relief VAS: visual analogue scale