Malmstrom 2004a.
Methods | RCT, DB, single oral dose, 6 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins then at 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours |
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Participants | Impacted third molar extraction N = 398 M = 147, F = 251 Mean age 21 years |
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Interventions | Etoricoxib 60 mg, n = 75 Etoricoxib 120 mg, n = 76 Etoricoxib 180 mg, n = 74 Etoricoxib 240 mg, n = 76 Ibuprofen 400 mg, n = 48 Placebo, n = 49 |
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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, 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 | Low 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 (48 to 76 participants) |