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 |
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Interventions | Intervention: meclofenamate 100 mg (N = 77); meclofenamate 200 mg (N = 80), and codeine 60 mg (N = 79) Comparison intervention: placebo (N = 79) |
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Outcomes |
Pain measured before 1st dose, 30 minutes after and thereafter hourly up to 6 hours |
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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 |
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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 |