Methods | Randomised, double blind, active (pethidine) control, single IM dose. Study duration 6 h. Baseline PI = severe Self assessment at t = 0.30, 1, then hourly up to 6 h. |
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Participants | Elective exploratory laparotomy N = 100 M 82, F 18 Mean age 40 years |
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Interventions | Dipyrone 2.5 g IM, n = 51 Pethidine 100 mg IM, n = 49 |
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Outcomes | PR: standard 5 point scale (0‐4) Adverse events |
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Notes | Oxford Quality Score: R1, DB1, W0. Total = 2 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 reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Study medication not indistinguishable, but administered by research worker who had no contact with other investigators |