Analgesic efficacy and pharmacokinetics of ketoprofen administered into a surgical site.
A series of three clinical trials in the oral surgery model evaluated the analgesic efficacy and pharmacokinetics of ketoprofen administered locally as a strategy for decreasing systemic exposure to nonsteroidal anti-inflammatory drugs (NSAIDs). A gel formulation was administered directly into extraction sites 1 hour following oral surgery, and pain intensity was evaluated for 6 hours. Significantly less pain was seen following peripheral administration of both 10 and 30 mg ketoprofen in comparison to the placebo. In a second study, peripheral administration of the 1 mg dose resulted in greater analgesia than oral administration of the same dose formulation or the placebo. The third study demonstrated lower plasma drug levels following the peripheral route of administration in comparison to oral administration of the same dose or ingestion of a 25 mg oral capsule. These data indicate that administration of an NSAID to a peripheral site of tissue injury results in greater analgesia than oral administration and suggests the potential for less drug toxicity through lower circulating drug levels.
Dionne
R A
RA
Pain and Neurosensory Mechanisms Branch, National Institute of Dental Research, National Institutes of Health, Bethesda, Maryland 20892, USA.
Gordon
S M
SM
Tahara
M
M
Rowan
J
J
Troullos
E
E
D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007660:Ketoprofen / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D010147:Pain Measurement / Q000187:drug effects*; D010149:Postoperative Pain / Q000097:blood / Q000188:drug therapy*; D014081:Tooth Extraction / Q000379:methods
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D007660:Ketoprofen