A. Sunshine et al., Onset and duration of analgesia for low-dose ketoprofen in the treatment of postoperative dental pain, J CLIN PHAR, 38(12), 1998, pp. 1155-1164
The objective of this single dose, double-blind study was to determine the
relative analgesic efficacy of low-dose ketoprofen (6.25 mg, 12.5 mg and 25
mg? compared with ibuprofen (200 mg) and placebo in 175 patients with mode
rate to severe postoperative pain secondary to extraction of impacted third
molars. Analgesia was measured during the B-hour period after administrati
on based on onset of relief, hourly and summary variables, and duration of
treatment effect. All active treatments were significantly more effective t
han placebo for many hourly measures and for the summary measures sum of pa
in intensity differences (SPID), sum of hourly pain relief values (TOTPAR),
time to peak pain relief, and patient global assessment of study medicatio
n. The three ketoprofen doses were significantly more effective than placeb
o beginning at 30 minutes, whereas ibuprofen was significantly better than
placebo beginning at 1 hour. A dose-response relationship was observed for
ketoprofen, with the two higher doses providing significantly greater analg
esia than the lower dose. However, a plateau effect was seen between the 12
.5-mg and 25-mg dose levels. A significantly greater proportion of patients
treated with each of the active treatments (ranging from 0.83 to 0.88) rep
orted onset of relief compared with placebo (0.20). The distribution functi
ons of onset of relief differed significantly among treatments, with ketopr
ofen 12.5 mg and 25 mg having a faster onset than ibuprofen 200 mg and keto
profen 6.25 mg. The duration of effect was generally shorter)cor ketoprofen
than for ibuprofen, and these difference were significant. This study prov
ides evidence that at the dose levels of 12.5 mg and 25 mg ketoprofen is an
effective analgesic in providing relief of postoperative dental pain. Keto
profen 12.5 mg and 25 mg provide significantly greater relief in the earlie
r time period, with a faster onset and shorter duration of effect than ibup
rofen 200 mg. The two higher doses of ketoprofen provided similar analgesia
, and no additional benefit was obtained by increasing the dose of ketoprof
en to 25 mg. Therefore, we conclude that ketoprofen 12.5 mg is an appropria
te dose for over-the-counter use. (C) 1998 The American College of Clinical
Pharmacology.