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. 2016 Jul 14;2016(7):CD011352. doi: 10.1002/14651858.CD011352.pub2
Methods Multi‐arm RCT – 4 group.
Participants Women > 15 years with moderate to severe episiotomy pain after normal vaginal birth at Women’s Hospital, Los Angeles County.
Women with a history of reaction or hypersensitivity to NSAID or salicylates, receiving perineal < 1 hour before entry to study, received analgesics, sedatives, psychotropic medications, or topical perineal anaesthetics within 4 hours of entering study or had an active disease that might interfere with the evaluation of study medications, were excluded.
Interventions Intervention: meclofenamate 200 mg (N = 55); meclofenamate 100 mg (N = 55) and codeine 60 mg (N = 53).
Comparison: placebo (N = 52).
Outcomes
  • Pain intensity (0 = none, 1 = slight, 2 = moderate, 3 = severe).

  • Pain relief (0 = none, 1 = a little, 2 = some, 3 = a lot, 4 = complete).

  • Additional medications (within 6 hours).

  • Side effects = this outcome was not considered in the analysis as adverse reactions were reported at 24 hours following the treatment regime (i.e. after more than single dose was administered).


Pain measures were assessed at baseline prior to treatment, at 30 minutes after and hourly thereafter to 6 hours.
Notes Codeine 60 mg not considered for the review as not an NSAID.
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 The attrition rate was 0%, but 5 of 220 (2%) participants were excluded from efficacy analysis because of protocol violation.
Selective reporting (reporting bias) Low risk Pre‐specified outcomes were all reported.
Other bias Low risk No differences in baseline characteristics.