Methods | RCT, DB single oral dose, 3 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins then hourly up to 12 h, and at 16 and 24 h |
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Participants | Impacted third molar extraction Mean age 22 years N = 171 M = 77, F = 94 |
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Interventions | Celecoxib 400 mg, n = 57 Ibuprofen 400 mg, n = 57 Placebo, n = 57 |
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Outcomes | PI: std 4-point scale PR: std 5-point scale Time to use of rescue medication Number of participants using rescue medication Number of participants reporting any adverse event and serious adverse events Number of participants withdrawing due to adverse event |
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Notes | Oxford Quality Score: R2, DB2, W1 Participants asked to refrain from rescue medication for 1 h |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “computer-generated randomization schedule, prepared before the start of the study” |
Allocation concealment (selection bias) | Low risk | Medication supplied in patient-specific carton. Identity of assignment contained in concealed section of label, which was removed at dispensing, and attached to patient case report form |
Blinding (performance bias and detection bias) All outcomes |
Low risk | Double-blind method. Placebo capsules or tablets identical in number and appearance to active treatments |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | All participants accounted for; analysis appropriate for relevant time interval |
Other bias | Unclear risk | Small treatment group size (57 participants) |