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. 2016 Jul 14;2016(7):CD011352. doi: 10.1002/14651858.CD011352.pub2
Methods Multi‐arm RCT – 3 groups.
Participants Hospitalised women with moderate or severe episiotomy pain after normal uncomplicated birth, New York.
Women with eclampsia or any other medical complication, allergic hypersensitivity to treatment drugs or had any analgesia or NSAID in 4 hours prior to study entry, were excluded.
Interventions Intervention: ibuprofen 400 mg (N = 36).
Comparison: placebo (N = 38) and acetaminophen 1000 mg (N = 37).
Outcomes
  • Pain intensity (4 point scale; 0 = none to 3 = severe).

  • Pain relief (5‐point scale; 0 = none to 4 = complete).

  • Overall evaluation (5‐point scale; 0 = poor to 5 = excellent).

  • Supplemental analgesia (after 1 hour).


Pain measured before medication, 30 minutes and 1‐4 hours after.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random code.
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 4 of 115 (3%) participants removed after randomisation due to re‐medicated but time not known and not specified from which group.
Selective reporting (reporting bias) Low risk Pre‐specified outcomes were all reported.
Other bias Low risk The groups were similar in terms of demographics and clinical features.