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. 2013 Nov 25;2013(11):CD003227. doi: 10.1002/14651858.CD003227.pub3
Methods Randomised, double blind, placebo control, single oral dose. Study duration 6 h
Baseline PI = severe
Self assessment at t = 0.15, 0.30, 1.0, 1.5 and then hourly up to 6 h.
Participants Post‐episiotomy or 2nd degree vaginal tear
N = 108
All F
Mean age: 24 years
Interventions Dipyrone 500 mg, n = 27
Ketoprofen 25 mg, n = 28
Ketoprofen 50 mg, n = 26
Placebo, n = 27
Outcomes PI: standard 4 point scale (0‐3)
PR: standard 5 point scale (0‐4)
PGE: non‐standard 4 point scale
Use of rescue medication
Adverse events
Withdrawals
Notes Oxford Quality Score: R1, DB1, W1. Total = 4
Remedication was allowed after 1 h
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Low risk "individual randomisation envelope for each patient entering the study "
Blinding (performance bias and detection bias) All outcomes Unclear risk Study medication not identical, but nurse prepared medication as indicated to total volume of 4 ml and administered it to the patient.
Administration of study medication and observation of patient carried out by two individuals to maintain the double‐blind character.