Analgesic efficacy and safety of (R)- ketoprofen in postoperative dental pain.
This double-blind, randomized, parallel-group study compared the analgesic efficacy and safety of single doses of (R)- ketoprofen 25 mg and 100 mg to that of acetaminophen 1,000 mg and placebo in 177 patients experiencing moderate to severe pain after surgical removal of their impacted third molars. Both (R)- ketoprofen 100 mg and acetaminophen 1,000 mg were significantly (P < 0.05) more efficacious than placebo for all summary analgesic measures. Other than a more rapid analgesic onset (45 minutes versus 60 minutes) for acetaminophen 1,000 mg, (R)- ketoprofen 100 mg and acetaminophen 1,000 mg were statistically equivalent to each other. The 25 mg dose of (R)- ketoprofen appeared to approach the analgesic threshold dose, being numerically but not statistically superior to placebo for all summary measures. There were no serious adverse events observed in this study, with the overall incidence of side effects being somewhat less in the (R)- ketoprofen groups than in the acetaminophen 1,000 mg group. (R)- Ketoprofen possesses analgesic activity and an acceptable side-effect profile in the oral surgery pain model.
Cooper
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Department of Clinical Research, Whitehall-Robins Healthcare, Madison, NJ, USA.
Reynolds
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DC
Reynolds
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B
Hersh
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EV
D000082:Acetaminophen / Q000627:therapeutic use; D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007660:Ketoprofen / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008964:Molar, Third / Q000601:surgery; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D014081:Tooth Extraction / Q000009:adverse effects*; D014095:Tooth, Impacted / Q000601:surgery
D000700:Analgesics; D010919:Placebos; D000082:Acetaminophen; D007660:Ketoprofen