Gleason 1987

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, in a hospital setting in Kansas. 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 3.5 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.
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 duration of 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	Pre‐specified outcomes were all reported.
Other bias	Low risk	The 4 treatment groups did not differ significantly with respect to demographic characteristics.