A series of three clinical trials in the oral surgery model evaluated the a
nalgesic efficacy and pharmacokinetics of ketoprofen administered locally a
s a strategy for decreasing systemic exposure to nonsteroidal anti-inflamma
tory drugs (NSAIDs). A gel formulation was administered directly into extra
ction sites 1 hour following oral surgery, and pain intensity was evaluated
for 6 hours. Significantly less pain was seen following peripheral adminis
tration of both 10 and 30 mg ketoprofen in comparison to the placebo. In a
second study, peripheral administration of the 10 mg dose resulted in great
er analgesia than oral administration of the same dose formulation or the p
lacebo. The third study demonstrated lower plasma drug levels following the
peripheral route of the same dose or ingestion of a 25 mg oral capsule. Th
ese data indicate that administration of an NSAID to a peripheral site of t
issue injury results in greater analgesia than oral administration and sugg
ests the potential for less drug toxicity through lower circulating drug le
vels.