title: Ketoprofen Dental Pain Study.
abstract: Ketoprofen is a nonsteroidal antiinflammatory drug, recently approved as an over-the-counter (OTC) analgesic at a 12.5 mg dosage strength. This is the first published study which explores the analgesic efficacy and safety of ketoprofen 12.5 mg in patients experiencing pain following the removal of impacted third molars. This study was single-dose, double-blind and randomized utilizing a 6-hour in-patient evaluation period. Patients ingested a single dose of ketoprofen 12.5 mg (n = 30), ketoprofen 37.5 mg (n = 32) or placebo (n = 15) when their post-surgical pain reached at least a moderate intensity on a 5-point categorical (CAT) scale and greater than 50 mm on a 100 mm visual analog scale (VAS). Measures of pain intensity and relief were gathered every 20 minutes for the first 2 hours, and then hourly from hours 3 through 6. Adverse drug reactions were also recorded as they occurred. Both dosages of ketoprofen were significantly more efficacious than placebo (two way ANOVAs, p < 0.05). For pain intensity difference (PID) and pain relief, the 12.5 mg dose exhibited statistical superiority from hours 1 through 3, while the 37.5 mg dose exhibited statistical superiority from 40 minutes through 4 hours. Ketoprofen 37.5 mg was significantly more efficacious than the 12.5 mg dose only at 40 minutes for PID(VAS) and relief, and at 60 minutes for PID(VAS). Both ketoprofen dosages displayed significantly greater 3-hr, 4-hr and 6-hr summary analgesic measures (SPID(VAS), SPID(CAT), TOTPAR) than placebo, with the exception of the 6-hr SPID(CAT) measure for ketoprofen 12.5 mg. No serious side effects were observed in this study. We conclude that ketoprofen in a dose range of 12.5 mg to 37.5 mg is a safe and effective analgesic for the relief of post-operative dental pain.
authors.affiliation: University of Pennsylvania School of Dental Medicine, Philadelphia, Pennsylvania, USA.
authors.forename: L M
authors.initials: LM
authors.lastname: Levin
authors.forename: S A
authors.initials: SA
authors.lastname: Cooper
authors.forename: N J
authors.initials: NJ
authors.lastname: Betts
authors.forename: D
authors.initials: D
authors.lastname: Wedell
authors.forename: D G
authors.initials: DG
authors.lastname: Hermann
authors.forename: C
authors.initials: C
authors.lastname: Lamp
authors.forename: S A
authors.initials: SA
authors.lastname: Secreto
authors.forename: E V
authors.initials: EV
authors.lastname: Hersh
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007660:Ketoprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008964:Molar, Third / Q000601:surgery; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000627:therapeutic use; D061646:Operative Time; D010147:Pain Measurement / Q000379:methods; D010149:Postoperative Pain / Q000188:drug therapy*; D010919:Placebos; D012449:Safety; D014081:Tooth Extraction / Q000379:methods*; D014095:Tooth, Impacted / Q000601:surgery; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004366:Nonprescription Drugs; D010919:Placebos; D007660:Ketoprofen