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. |
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Participants | Post‐episiotomy or 2nd degree vaginal tear N = 108 All F Mean age: 24 years |
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Interventions | Dipyrone 500 mg, n = 27 Ketoprofen 25 mg, n = 28 Ketoprofen 50 mg, n = 26 Placebo, n = 27 |
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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 |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 4 Remedication was allowed after 1 h |
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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. |