Analgesic efficacy of single oral doses of lumiracoxib and ibuprofen in patients with postoperative dental pain.
This randomised, double-blind study compared single dose lumiracoxib (a cyclooxygenase-2 selective inhibitor) 100 and 400 mg, ibuprofen 400 mg and placebo in patients with postoperative dental pain over 12 h. The primary efficacy variable was pain intensity difference. Lumiracoxib 400 mg and ibuprofen were superior to placebo from 1 to 12 h post dose while lumiracoxib 100 mg was superior from 1.5 to 9 h. Lumiracoxib 400 mg demonstrated the fastest median time to onset of analgesia (37.4 min) followed by ibuprofen (41.5), and lumiracoxib 100 mg (52.4; all p < or = 0.001 vs. placebo). Median time to rescue medication (h) was longer for lumiracoxib 400 mg (> or = 12), lumiracoxib 100 mg (approximately 7) and ibuprofen (approximately 8) than placebo (approximately 2; all p < or = 0.001 vs. placebo). Patients rated lumiracoxib 400 mg superior to the other active treatments (p < 0.05); lumiracoxib 100 mg was comparable with ibuprofen and superior to placebo (p < 0.001). Lumiracoxib provided rapid, effective and well-tolerated analgesia.
Zelenakas
K
K
Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1080, USA.
Fricke
J R
JR
Jayawardene
S
S
Kellstein
D
D
D000293:Adolescent; D000328:Adult; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004008:Diclofenac / Q000031:analogs & derivatives; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008297:Male; D008964:Molar, Third / Q000601:surgery; D009930:Organic Chemicals / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000188:drug therapy*; D010865:Pilot Projects; D014081:Tooth Extraction; D016896:Treatment Outcome
D016861:Cyclooxygenase Inhibitors; D009930:Organic Chemicals; D004008:Diclofenac; C473384:lumiracoxib; D007052:Ibuprofen