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. 2013 Nov 25;2013(11):CD003227. doi: 10.1002/14651858.CD003227.pub3
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.
Participants Orthopaedic surgery ‐ total hip replacement
N = 106
M 48, F 58
Mean age 62 years
Interventions Dipyrone 2 g IM, n = 35
Ibuprofen arginine 400 mg (oral), n = 36
Placebo, n = 35
Outcomes PI: 100 mm VAS (no pain‐unbearable pain)
PGE: standard 5 point scale
Use of rescue medication
Adverse events
Withdrawals
Notes Oxford Quality Score: R1, DB2, W1. Total = 4
Rescue medication allowed after 1 h
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"