Methods | RCT, DB, DD, placebo and active controlled parallel-group study, 12 hour single dose phase, followed by multi-dose phase up to 96 hours. Medication administered when pain intensity was moderate to severe | |
Participants | Post operative total knee or hip arthroplasty surgery Male and females Mean age 64 years (SD 11.0, range 18 to 80 years) N=180 |
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Interventions | Lumiracoxib 400 mg, n = 60 Naproxen 500 mg, n = 60 Placebo, n = 60 |
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Outcomes | ≥50% PR over six hours Time to onset of analgesia Use of rescue medication Adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5 | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “validated automated system” |
Allocation concealment (selection bias) | Low risk | Remote allocation |
Blinding (performance bias and detection bias) All outcomes |
Low risk | “double dummy” |