Skip to main content
. 2021 Jan 11;2021(1):CD011352. doi: 10.1002/14651858.CD011352.pub3

Yonkeura 1987.

Study characteristics
Methods Multi‐arm RCT – 4 group
Participants Women > 15 years with moderate to severe episiotomy pain after normal vaginal birth
Women’s Hospital, Los Angeles County, USA
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
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 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 violations
Selective reporting (reporting bias) Low risk Outcomes prespecified in the study methods were all reported
Other bias Low risk No differences in baseline characteristics