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. 2013 Nov 25;2013(11):CD003227. doi: 10.1002/14651858.CD003227.pub3
Methods Randomised, double blind, active control (dexketoprofen), single and multiple oral dose. Study duration 6 h for single dose phase and 3 days for multiple dose phase.
Baseline PI = moderate or severe
Self assessment at t = 0, 0.15, 0.30, 1, then hourly up to 6 h for single dose phase.
Participants Impacted third molar extraction
N = 120
M 46, F 74
Mean age 25 years
Interventions Dipyrone 575 mg, n = 40
Dexketoprofen‐trometamol 12.5 mg, n = 38
Dexketoprofen‐trometamol 25 mg, n = 42
Outcomes PI: standard 4 point scale (0‐3) and 100mm VAS (no pain to maximum pain)
PR: standard 5 point scale (0‐4)
PGE: non‐standard 4 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 reported
Blinding (performance bias and detection bias) All outcomes Low risk "identical capsules"