Nz. Olson et al., Onset of analgesia for liquigel ibuprofen 400 mg, acetaminophen 1000 mg, ketoprofen 25 mg, and placebo in the treatment of postoperative dental pain, J CLIN PHAR, 41(11), 2001, pp. 1238-1247
Ibuprofen is a peripherally acting nonsteroidal anti-inflammatory drug indi
cated for analgesia, antipyresis, and various arthritic conditions. A solub
ilized 200 mg liquigel formulation of ibuprofen has been shown to have a mo
re rapid rate of absorption compared with ibuprofen 200 mg tablets. Ibuprof
en liquigels have a kinetic profile similar to ibuprofen suspension, with b
oth a higher C-max and an earlier t(max) than any solid tablet. The objecti
ve of this single-dose, double-blind, triple-dummy, parallel-group study wa
s to assess the time to onset of relief and overall analgesic efficacy of l
iquigel ibuprofen 400 mg, ketoprofen 25 mg compared with acetaminophen 1000
mg, and placebo in 239 patients with moderate or severe pain following thi
rd molar extractions. Treatments were compared over 6 hours using standard
scales for pain intensity and relief and stopwatch onset of meaningful reli
ef. All active treatments provided meaningful relief significantly faster c
ompared with placebo. Ibuprofen provided significantly faster relief compar
ed with acetaminophen and ketoprofen. By the end of the study (6 h), onset
of meaningful relief was achieved by 36%, 99%, 96%, and 88% of the patients
in the placebo, ketoprofen, ibuprofen, and acetaminophen groups, respectiv
ely. The median times to onset of relief were > 6 hours for placebo, 25.5 m
inutes for ketoprofen, 24.2 minutes for ibuprofen, and 29.9 minutes for ace
taminophen. In addition, both ibuprofen and ketoprofen showed statistical s
uperiority over acetaminophen at earlier time points on the time-effect cur
ves for pain relief and pain intensity difference. Consistent results were
seen with respect to the 6-hour summary efficacy variables: the three activ
e treatments were significantly better than placebo, and ibuprofen was sign
ificantly better than both acetaminophen and ketoprofen. Liquigel ibuprofen
400 mg was shown to provide faster relief and superior overall efficacy co
mpared with ketoprofen 25 mg, acetaminophen 1000 mg, and placebo. No seriou
s adverse effects were reported in this single-dose study.