Daniels 2011.
Methods | RCT, DB, 4 oral doses over 24 hours (single active dose of etoricoxib), 5 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins, hourly up to 8 hours, then at 10, 12, 20, and 24 hours |
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Participants | Impacted third molar extraction N = 588 M = 248, F = 340 Mean age 22 years |
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Interventions | Etoricoxib 90 mg, n = 191 Etoricoxib 120 mg, n = 97 Ibuprofen 600 mg (6‐hourly), n = 192 Paracetamol + codeine 600/60 mg (6‐hourly), n = 62 Placebo, n = 46 | |
Outcomes | PI: standard 4‐point scale 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, DB1, W1 Rescue medication available for inadequate response (no details of timing) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Medication provided in numbered containers; participant allocated to next number in sequence |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "in house blinding conditions". "Investigator, study nurse, patients, monitors, laboratory personnel remained blinded throughout the study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants accounted for; analysis appropriate for relevant time interval |
Other bias | High risk | Small treatment group size (97 to 192 active, 46 placebo participants) |