Methods | RCT, DB, DD, placebo and active controlled, parallel-group 12 hour study in patients with moderate to severe pain | |
Participants | Post-operative dental surgery, third molar extraction Male and females Age >17 years Mean age 22 years SD 5.0 N = 202 |
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Interventions | Lumiracoxib 400 mg, n = 50, 100 mg n = 51 Ibuprofen 400 mg n = 51 Placebo n = 50 |
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Outcomes | Patients with >50% PR over six hours: lumiracoxib 32/50, Placebo 6/50 Time to remedication: Lumiracoxib >12 hours Placebo 2.0 hours Time to onset: Lumiracoxib 0.6 hours Placebo >12 hours |
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Notes | One serious adverse event due to a DVT in a placebo patient QS = 4 (R1, D2, W1) |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |
Key:
DB - Double blind
DD - Double Dummy
DVT - Deep vein thrombosis
PR - Pain relief
RCT - Randomised Controlled Trial