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, and 90 mins, then at 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 h |
|
Participants | Impacted third molar extraction Mean age 22 years N = 304 M = 111, F = 193 |
|
Interventions | Celecoxib 400 mg, n = 51 Placebo, n = 52 CS-706 also tested at 10, 50, 100, 200 mg |
|
Outcomes | PI: std 4-point scale PR: std 5-point scale PGE: std 5-point scale Time to use of rescue medication Number of participants using rescue medication |
|
Notes | Oxford Quality Score: R1, DB2, W1 Participants asked to refrain from rescue medication for 1.5 h |
|
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Low risk | Investigator, all study staff and related personnel were unaware of treatment assignment |
Blinding (performance bias and detection bias) All outcomes |
Low risk | Double-dummy method. Matching tablets for CS-706 and corresponding placebo. Celecoxib and corresponding placebo capsules differed in markings, so participant blindfolded and treatment administered by a third party |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | Participants accounted for; analysis appropriate for relevant time interval |
Other bias | Unclear risk | Small treatment group size (50 to 51 participants) |