Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain.
OBJECTIVE
To determine analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with acetaminophen/codeine 600/60 mg, we conducted a double-blind, randomized, placebo- and active-comparator-controlled, parallel-group study.


METHODS
Patients (N = 390) experiencing moderate or severe pain postextraction of 2 or more third molars, with at least 1 mandibular impaction, were randomized to placebo (n = 30), rofecoxib (n = 180), or codeine/acetaminophen 60/600 mg (n = 180). Time to confirmed perceptible pain relief, and patient evaluations of pain intensity, pain relief, and global assessments were recorded.


RESULTS
For total pain relief over 6 hours (primary end point), rofecoxib was superior to codeine/acetaminophen (15.5 vs 10.7; P < .001). Rofecoxib was statistically significantly superior to codeine/acetaminophen with respect to TOPAR4, patient global assessment, peak pain relief, and duration of analgesic effect. Median onset of analgesia was similar for both drugs. The codeine/acetaminophen group had more patients with 1 or more adverse events.


CONCLUSIONS
Rofecoxib provided superior analgesic efficacy compared with codeine/acetaminophen with fewer gastrointestinal and nervous system adverse events.
Chang
David J
DJ
Clinical Development, Merck & Co, Inc, West Point, Pennsylvania, USA.
Bird
Steven R
SR
Bohidar
Norman R
NR
King
Thomas
T
D000082:Acetaminophen / Q000627:therapeutic use; D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000704:Analysis of Variance; D003061:Codeine / Q000627:therapeutic use*; D003257:Consumer Product Safety; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005157:Facial Pain / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008964:Molar, Third / Q000601:surgery; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D013450:Sulfones / Q000627:therapeutic use*; D014081:Tooth Extraction / Q000009:adverse effects
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D052246:Cyclooxygenase 2 Inhibitors; D004338:Drug Combinations; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D000082:Acetaminophen; D003061:Codeine