Yonkeura 1987.
Methods | Randomised, double blind, 4 parallel groups. Single and multiple oral dose phases Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 30, 60 mins, then hourly to 6 hours |
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Participants | Episiotomy N = 218 All F Mean age 24 years |
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Interventions | Codeine 60 mg, n = 53 Meclofenamate 100 mg, n = 55 Meclofenamate 200 mg, n = 55 Placebo, n = 52 |
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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 | Unclear risk | "identically appearing capsules" |
DB ‐ double blind, 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, W ‐ withdrawals h ‐ hours, pts ‐ participants, mins ‐ minutes