Sunshine 1987.
Methods | Randomised, double blind, 5 parallel groups. Single oral dose Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 30, 60 mins, then hourly to 4 hours |
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Participants | Episiotomy, Cesarian section or gynaecological operations N = 195 All F Mean age 26 years |
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Interventions | Codeine 60 mg, n = 37 Ibuprofen 40mg, n = 38 Ibuprofen + Codeine 400/60 mg, n = 40 Ibuprofen + Codeine 200/30 mg, n = 40 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 Qualtiy Score: R1, DB2, W1. Total = 4 Rescue medication allowed after 1 hour |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Not described |
Allocation concealment? | Unclear risk | Not described |
Blinding? All outcomes | Low risk | "All unit doses were identical in appearance and packaging" |