The analgesic efficacy of etoricoxib compared with oxycodone/acetaminophen in an acute postoperative pain model: a randomized, double-blind clinical trial.
Our objective in this study was to compare the analgesic effects of etoricoxib and oxycodone/acetaminophen in a postoperative dental pain model. Patients experiencing moderate to severe pain after extraction of two or more third molars were randomized to single doses of etoricoxib 120 mg (n = 100), oxycodone/acetaminophen 10/650 mg (n = 100), or placebo (n = 25). The primary end-point was total pain relief over 6 h. Other end-points included patient global assessment of response to therapy; onset, peak, and duration of effect; and rescue opioid analgesic use. Active treatments were statistically significantly superior to placebo for all efficacy measures. Total pain relief over 6 h for etoricoxib was significantly more than for oxycodone/acetaminophen (P < 0.001). Patient global assessment of response to therapy at 6 and 24 h was superior for etoricoxib. Both drugs achieved rapid onset, although the time was faster for oxycodone/acetaminophen by 5 min. The peak effect was similar for both drugs. Compared with oxycodone/acetaminophen patients, etoricoxib patients experienced a longer analgesic duration, had a smaller percentage requiring rescue opioids during 6 and 24 h, and required less rescue analgesia during 6 and 24 h. Oxycodone/acetaminophen treatment resulted in more frequent adverse events (AEs), drug-related AEs, nausea, and vomiting compared with etoricoxib treatment. In conclusion, etoricoxib 120 mg provided superior overall efficacy compared with oxycodone/acetaminophen 10/650 mg and was associated with significantly fewer AEs.
Chang
David J
DJ
*Merck & Co., Inc., West Point, Pennsylvania; and †Scirex Corporation, Austin, Texas.
Desjardins
Paul J
PJ
King
Thomas R
TR
Erb
Tara
T
Geba
Gregory P
GP
D000082:Acetaminophen / Q000008:administration & dosage*; D000208:Acute Disease; D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D008297:Male; D010098:Oxycodone / Q000008:administration & dosage*; D010149:Postoperative Pain / Q000188:drug therapy*; D011725:Pyridines / Q000627:therapeutic use*; D013450:Sulfones / Q000627:therapeutic use*
D011725:Pyridines; D013450:Sulfones; D000082:Acetaminophen; D010098:Oxycodone; D000077613:Etoricoxib