Sunshine 1987.
Methods | R, DB, 5 parallel groups. Single oral dose Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 0.5, 1, 2, 3, 4 h |
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Participants | Episiotomy, Caesarian section or gynaecological operations N = 195 All F Mean age 26 years |
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Interventions | Ibuprofen + codeine 200/30 mg, n = 40 Ibuprofen + codeine 400/60 mg, n = 40 Ibuprofen 40 mg, n = 38 Codeine 60 mg, n = 37 Placebo, n = 40 |
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Outcomes | PI: standard 4‐point scale PR: standard 5‐point scale Use of rescue medication Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 Rescue medication 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) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All unit doses were identical in appearance and packaging" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "All unit doses were identical in appearance and packaging" |
Size | High risk | < 50 participants per treatment arm |
DB: double‐blind; F: female; M: male; N: number of participants in study; n: number of participants in treatment arm; PGE: patient global evaluation; PI: pain intensity; PR: pain relief; R: randomised; VAS: visual analogue scale; W: withdrawals