| Methods | Randomised, double blind, placebo control, single oral dose. Duration of study 4 h Baseline PI = moderate and severe Self assessment at t = 0.15, 0.30, 1, 2 h and 4 h. |
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| Participants | Elective abdominal or urological surgery N = 100 (88 analysed ‐ 12 did not fulfil eligibility criteria) M 47, F 53 Mean age 49 years |
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| Interventions | Dipyrone 2.5 g, n = 51 (44 analysed) Tramadol 100 mg, n = 49 (44 analysed) |
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| Outcomes | PI: 100 mm VAS (no pain‐worst possible pain) PR: 100 mm VAS (no PR‐complete PR) PGE: 100 mm VAS (ineffective‐excellent) Use of rescue medication Adverse events Withdrawals |
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| Notes | Oxford Quality Score: R1, DB1, W1. Total = 4 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomisation list" |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Study drug administered by one investigator and assessed in the presence of another who was unaware of the allocation |
DB ‐ double blind; F ‐ female; M ‐ male; N ‐ total 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