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. 2016 Jul 14;2016(7):CD011352. doi: 10.1002/14651858.CD011352.pub2
Methods Parallel RCT ‐ 2 groups.
Participants Women with mediolateral episiotomy without a third‐ or fourth‐degree tear after a normal uncomplicated delivery, at term, who had not used any analgesic drugs within 4 hours preceding the study at the King Chulalongkorn Memorial Hospital between June 2006 and November 2006.
Women with an allergy to either study drug, a history of drug dependence, regular use of analgesic drugs before or during pregnancy, and any medical condition known to be potentially exacerbated by acetaminophen or NSAIDS, including a history of gastrointestinal ulcer or bleeding, significant renal or liver impairment and asthma, postpartum haemorrhage or any other major postpartum complications, were excluded.
Interventions Intervention: ibuprofen 400 mg (N = 106).
Comparison: acetaminophen 500 mg (N = 104).
Outcomes
  • Pain severity (10‐cm VAS from 0 = no pain to 10 = worst pain ever).

  • Side effects.

  • Rescue medication; supplemental analgesic after 4‐hour evaluation as a rescue drug.

  • Maternal satisfaction with relief of perineal pain (after 24 hours of treatment = N/A for review).


An initial pain rating was recorded before participants took the first dose of analgesia and at 1, 2, 3 and 4 hours after.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No clear statement on method used; states only "stratified random sampling technique".
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 Low risk Outcome assessor blind to treatment group.
Incomplete outcome data (attrition bias) All outcomes Low risk Data provided for all 210 participants (0% attrition rate in all groups).
Selective reporting (reporting bias) Low risk Pre‐specified outcomes were all reported.
Other bias Low risk Treatment groups were similar in demographic data and clinical features; the severity of perineal pain did not differ between the groups before the treatment.