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. 2021 Jan 11;2021(1):CD011352. doi: 10.1002/14651858.CD011352.pub3

Gleason 1987.

Study characteristics
Methods Multi‐arm RCT – 4 groups
Participants Women aged 15 years and older with moderate to severe episiotomy pain within 24 hours of an uncomplicated vaginal birth and could read, comprehend and sign a consent form
Hospital setting in Kansas, USA
Nursing mothers, women with a history of reaction or hypersensitivity to NSAIDs or salicylates or women who had received topical perineal anaesthetic or analgesic, NSAID, sedative or psychotropic medication within 3½ hours of study entry, were excluded
Interventions Intervention: meclofenamate 100 mg (N = 77); meclofenamate 200 mg (N = 80), and codeine 60 mg (N = 79)
Comparison intervention: placebo (N = 79)
Outcomes
  • Pain intensity (0 = none, 1 = slight, 2 = moderate and 3 = severe)

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

  • Adverse effects (N/A for analysis as unclear if these are after 1st dose or subsequent doses)

  • Supplemental analgesia (not provided for meclofenamate 200 mg)

  • Global rating of poor, fair and good (but unclear if rated after 1st dose or all doses – N/A for analysis)


Pain measured before 1st dose, 30 minutes after and thereafter hourly up to 6 hours
Notes Codeine 60 mg was not considered in the review as not a NSAID
Dates of study: NR
Funding sources: NR
Declarations of interest: NR
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 Only states each dose was packaged separately
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 Of 327 women selected, 12 (4%) were excluded from the analysis due to protocol violations (taking other analgesic medication during the study). The attrition rates in the individual groups were: 1 of 81 (1%) in the meclofenamate 200 mg group, 3 of 80 (4%) in the meclofenamate 100 mg group, 3 of 83 (4%) in the placebo group (and 3 of 83 (4%) in the codeine group which was not included in this review)
Selective reporting (reporting bias) Low risk Prespecified outcomes were all reported
Other bias Low risk The 4 treatment groups did not differ significantly by demographic characteristics