Open AccessROFECOXIB COMPARED TO OXYCODONE/ACETAMINOPHEN FOR POSTOPERATIVE DENTAL PAIN
Author(s) -
James R. Fricke,
Ppd Development,
T.C. Vassil,
Paul Kotey,
Scott Korn
Publication year - 2002
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1046/j.1526-4637.2002.202431.x
Subject(s) - medicine , acetaminophen , oxycodone , rofecoxib , anesthesia , pain management , postoperative pain , pain medicine , opioid , anesthesiology , cyclooxygenase , enzyme , biochemistry , chemistry , receptor
James Fricke, DDS, MSD, PPD Development, Theodore Vassil, MS, Merck Research Laboratories, Paul Kotey, PhD, Merck Research Laboratories, Scott Korn, MD, Merck Research Laboratories Background: Rofecoxib (ROF) is a selective cyclooxygenase‐2(COX‐2) inhibitor approved for the treatment of acute pain and primary dysmenorrhea as well as osteoarthritis. Aim: This single dose, double‐blind, randomized placebo‐controlled trial was undertaken to compare the analgesic efficacy of ROF 50 mg (n=90), Oxycodone/Acetaminophen 5/325 mg (Oxy/APAP) (n=91) and placebo (PBO) (n=31). Methods: Patients with moderate to severe pain following extraction of at least 2 third molars (at least one bony impaction) were randomized to study medication, rated pain intensity and pain relief at prescribed times over 24 hours, and recorded time to perceptible pain relief and time to meaningful pain relief by stopwatch. Primary comparisons were response to therapy over the first 6 hour time period based on recommended dosing for Oxy/APAP. Results: Both ROF and Oxy/APAP were significantly greater than PBO in all measures of onset, peak, duration, and overall analgesic effect, including TOPAR6 (Total Pain Relief Score over 6 hours) and global response to therapy at 6 hours. ROF demonstrated significantly greater efficacy than Oxy/APAP on all measures of overall analgesic effect, including TOPAR6, TOPAR4 and global response to therapy at 6 and 24 hours. Compared to Oxy/APAP, ROF had significantly greater overall and peak analgesic effect, significantly longer duration of analgesic effect, and similar time to onset of analgesic effect. ROF and PBO had generally similar adverse experience profiles; compared to Oxy/APAP, ROF patients had significantly fewer episodes of nausea (19% vs 40%) and vomiting (7% vs 23%). Conclusion: Rofecoxib 50 mg was more effective than Oxycodone/Acetaminophen 5/325 mg for relief of dental pain.