Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: A randomized, controlled trial

• Published in: Clinical therapeutics Vol. 21; no. 6; pp. 943 - 953
• Main Authors: Morrison, Briggs W., Christensen, Steven, Yuan, Weiying, Brown, Jean, Amlani, Susan, Seidenberg, Beth
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 01-06-1999; Excerpta Medica
• Subjects: Adolescent; Adult; analgesic; Analgesics; Analgesics, Non-Narcotic - adverse effects; Analgesics, Non-Narcotic - therapeutic use; Biological and medical sciences; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors - adverse effects; Cyclooxygenase Inhibitors - therapeutic use; cyclooxygenase-2-specific inhibitor; Double-Blind Method; Female; Humans; ibuprofen; Ibuprofen - therapeutic use; Isoenzymes - metabolism; Lactones - adverse effects; Lactones - therapeutic use; Male; Medical sciences; Membrane Proteins; Molar, Third - surgery; Neuropharmacology; Pain, Postoperative - drug therapy; Pharmacology. Drug treatments; Placebos; postoperative dental pain; Prostaglandin-Endoperoxide Synthases - metabolism; rofecoxib; Substrate Specificity; Sulfones; Tooth Extraction - adverse effects; rofecoxib; postoperative dental pain; ibuprofen; cyclooxygenase-2-specific inhibitor; analgesic; Human; Postoperative; Prostaglandin-endoperoxide synthase; Enzyme; Isozyme; Toxicity; Treatment efficiency; Dental disease; Enzyme inhibitor; Non steroidal antiinflammatory agent; Analgesia; Chemotherapy; Analgesic; Pain; Treatment; Surgery; Ibuprofen; Arylpropionic acid derivatives; Oxidoreductases; Tooth; Comparative study
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(99)80016-2

Previous data have suggested that rofecoxib, a cyclooxygenase (COX)-2-specific inhibitor, had analgesic effects similar to those of the nonsteroidal anti-inflammatory drugs when tested in the post-dental surgery pain model. The objective of this parallel-group, double-masked, randomized, placebo- and active comparator-controlled clinical trial was to assess more fully the analgesic efficacy of rofecoxib in the treatment of postoperative dental pain. After dental surgery, 151 patients (50.3% women; mean age, 18.3 years; 93.4% white) experiencing moderate-to-severe pain were to receive a single dose of placebo, rofecoxib 50 mg, or ibuprofen 400 mg. Analgesic efficacy was assessed for up to 24 hours postdose using self-administered questionnaires. Tolerability was assessed using spontaneous reports of adverse experiences, physical findings, and laboratory measurements. The results of this study demonstrated that rofecoxib 50 mg was more effective than placebo on all measures of analgesic efficacy. Rofecoxib 50 mg exhibited overall analgesic effects, onset of analgesia, and peak analgesic effects that were not significantly different from those of ibuprofen 400 mg, with a significantly longer duration of action (
P < 0.05). We concluded that rofecoxib was efficacious in the treatment of postoperative dental pain and that COX-2-derived prostanoids play a role in treatment of the pain associated with dental surgery.