Wisanto 1981

Methods	Parallel RCT – 2 groups.
Participants	Primiparas over 18 years old, had deliveries and episiotomies without complications and moderate to severe pain within 48 hours of procedure with an intensity of at least 60% on a VAS in Belgium. All participants had undergone medio‐lateral episiotomies with 3‐4 non‐absorbable surgical sutures using a local anaesthetic. Women with mild pain (< 60% on VAS), breastfeeding and excessive anxiety or emotional instability, were excluded. 1 dose of rescue analgesia was permitted in cases of excessive pain 2 hours after study drugs administered ‐ all other treatments were excluded.
Interventions	Intervention: antrafenine 300 mg (N = 30). Comparison: placebo (N = 30).
Outcomes	Total pain score reported by the participant and the investigator (0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain). Pain Intensity difference. Overall efficacy (nil, moderate, good or very good). Onset and duration of action. Side effects. Rescue analgesia. Pain measured at baseline, before drug administration, and hourly thereafter up to 6 hours. Only 6‐hour data included in the review (4‐hour 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	States identical‐appearing tablets but no other details.
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	2 of 60 (3%) of participants were excluded from the study after taking another analgesic (1 (3%) in each group).
Selective reporting (reporting bias)	Low risk	Pre‐specified outcomes were all reported.
Other bias	High risk	Delay between episiotomy and drug intake was significantly shorter in the placebo group; also 16 placebo‐treated patients withdrew from the study due to lack of efficacy compared to 5 in the antrafenine group. (Participants who withdrew from the study due to lack of efficacy were still included in the analysis: their last self‐rating on VAS was repeated.)