Rasmussen 2005.
Methods | RCT, DB, single and multiple oral doses, 3 parallel groups Medication administered when baseline pain reached a moderate to severe intensity, after withdrawal of patient controlled analgesia. Patient assessment at 0, 30, 60, 90, 120 mins, then hourly to 8 hours, then at 10, 12, 20, and 24 hours for the single‐dose study |
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Participants | Orthopaedic surgery (40% hip, 60% knee) N = 228 M = 90, F = 138 Mean age 65 years |
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Interventions | Etoricoxib 120 mg, n = 80 Naproxen sodium (CR) 1100 mg, n = 73 Placebo, n = 75 |
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Outcomes | PR: standard 5‐point scale PGE: standard 5‐point scale Time to use of rescue medication Number of participants using rescue medication Number of participants reporting adverse events and serious adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1 Participants asked to refrain from using rescue medication for 90 mins |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated allocation schedule" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double‐dummy method. "matching placebo tablet" for both active treatments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants accounted for; analysis appropriate for relevant time interval |
Other bias | Unclear risk | Small treatment group size (73 to 80 participants) |
DB ‐ double‐blind; F ‐ female; M ‐ male; N ‐ total number in trial; n ‐ number in treatment arm; PI ‐ pain intensity; PR ‐ pain relief; PGE ‐ patient global evaluation; R ‐ randomised; RCT ‐ randomised controlled trial; W ‐ withdrawals