Methods | Randomised, double blind, placebo control, single and multiple oral dose phases. Duration of single dose phase 5 h. Baseline PI = ≥50/100 mm Self assessment at t = 0, 0.15, 0.30, 1, then hourly up to 5 h. |
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Participants | Orthopaedic surgery ‐ total hip replacement N = 106 M 48, F 58 Mean age 62 years |
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Interventions | Dipyrone 2 g IM, n = 35 Ibuprofen arginine 400 mg (oral), n = 36 Placebo, n = 35 |
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Outcomes | PI: 100 mm VAS (no pain‐unbearable pain) PGE: standard 5 point scale Use of rescue medication Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4 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 (performance bias and detection bias) All outcomes | Low risk | "double dummy" |