The analgesic effect of etoricoxib relative to that of cetaminophen analgesics: a randomized, controlled single-dose study in acute dental impaction pain.
BACKGROUND
To compare the analgesic effect of single doses of etoricoxib 120 mg, oxycodone/ acetaminophen 10 mg/650 mg and codeine/ acetaminophen 60 mg/600 mg in acute pain using the dental impaction model.


METHODS
In this randomized, double-blind, placebo-controlled, parallel-group study, patients reported pain intensity and pain relief (16 times) and global scores (twice) during a 24-h period. The primary endpoint was the overall analgesic effect, total pain relief over 6 h (TOPAR6). Other endpoints were patient global evaluation, time to onset (2-stopwatch method), duration of analgesic effect (median time to and amount of rescue medication use). Tolerability was evaluated by overall and opioid-related (nausea and vomiting) adverse experiences.


RESULTS
302 patients (mean age 23; 63% women; 63 % White) were randomized to etoricoxib 120 mg, oxycodone/acetaminophen 10 mg/650 mg, codeine/acetaminophen 60 mg/600 mg, and placebo (2:2:1:1). Etoricoxib demonstrated significantly greater overall analgesic efficacy (TOPAR6) (13.2 units) versus oxycodone/acetaminophen (10.2 units); and codeine/acetaminophen (6.0 units); p < 0.001 for all. All active treatments were superior to placebo. Median time to onset was significantly (p < 0.001) shorter for oxycodone/acetaminophen (20 min) and numerically but not significantly shorter (p = 0.259) for codeine/acetaminophen (26 min) compared with etoricoxib (40 min). Etoricoxib (24 h) had a significantly longer lasting analgesic effect than oxycodone/acetaminophen (5.3 h), codeine/acetaminophen (2.7 h), and placebo (1.7 h) (p < 0.001 for all). Etoricoxib patients experienced fewer clinical adverse experiences than patients on oxycodone/acetaminophen and codeine/acetaminophen, specifically, significantly (p < 0.05) fewer episodes of nausea.


CONCLUSIONS
Etoricoxib 120 mg provided superior overall analgesic effect with a smaller percentage of patients experiencing nausea versus both oxycodone/acetaminophen 10 mg/650 mg and codeine/acetaminophen 60 mg/600 mg.
Malmstrom
Kerstin
K
Departments of Clinical Immunology and Analgesia, Merck Research Laboratories, Rahway, NJ, USA.
Ang
Jennifer
J
Fricke
James R
JR
Shingo
Sumiko
S
Reicin
Alise
A
D000082:Acetaminophen / Q000008:administration & dosage / Q000627:therapeutic use*; D000208:Acute Disease; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use*; D000704:Analysis of Variance; D003061:Codeine / Q000008:administration & dosage / Q000627:therapeutic use*; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D008297:Male; D010098:Oxycodone / Q000008:administration & dosage / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D016016:Proportional Hazards Models; D011725:Pyridines / Q000008:administration & dosage / Q000627:therapeutic use*; D013450:Sulfones / Q000008:administration & dosage / Q000627:therapeutic use*; D014095:Tooth, Impacted; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D016861:Cyclooxygenase Inhibitors; D004338:Drug Combinations; D011725:Pyridines; D013450:Sulfones; D000082:Acetaminophen; D010098:Oxycodone; D003061:Codeine; D000077613:Etoricoxib