Movilia 1989

Methods	Parallel RCT– 2 groups.
Participants	Women aged 18‐38 years with intense post‐episiotomy pain requiring analgesia at Legnano Civil Hospital, Italy. Women with liver or kidney failure, peptic ulcer and hypersensitivity to paracetamol or NSAID, were excluded.
Interventions	Intervention: aceclofenac single tablet 100 mg (N = 30; pain intensity could not be assessed in 1 due to vomiting; N = 29). Comparison: paracetamol 650 mg (N = 30).
Outcomes	Pain intensity (VAS 0‐100 with 0 = no pain and 100 = extremely severe pain); and rated by investigator on 5‐point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = extremely severe). Overall global efficacy (0 = unsatisfactory, 1 = fair, 2 = excellent). Overall global tolerability (0 = unsatisfactory, 1 = fair, 2 = good). Pain assessed before treatment administration, at 30 minutes after and hourly thereafter through to 6 hours.
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	No clear statement.
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	1 (3%) of 30 lost to analysis for pain intensity in aceclofenac 100 mg group due to vomiting. 0% attrition rate for the paracetamol 650 mg group.
Selective reporting (reporting bias)	Low risk	Pre‐specified outcomes were all reported.
Other bias	Low risk	Randomisation produced 2 homogenous groups.