Pregabalin is an analogue of the inhibitory neurotransmitter gamma-aminobut
yric acid. In preclinical models, it has shown activity as an analgesic age
nt. A randomized, double-blind, placebo-controlled, parallel-group trial wa
s undertaken to compare pregabalin to placebo and 400 mg of ibuprofen using
a dental pain model. Study medication was administered postoperatively to
patients who had undergone elective surgery to remove one or two third mola
rs, at least one of which was mandibular and fully or partially impacted in
bone. The study was conducted in the UK at a single centre and evaluated p
regabalin at doses of 50 and 300 mg. Primary efficacy parameters included p
ain relief (PR), pain intensity difference (PID), pain relief intensity dif
ference (PRID), time to onset of analgesia, and duration of analgesia. The
patient's global impression of the study medication was used as a secondary
efficacy parameter. Efficacy data were evaluated for the intent-to-treat (
ITT) population, defined as all randomized patients who took study medicati
on. Results showed that there were statistically significant differences in
PR, PID, and PRID between the 300-mg pregabalin group and placebo. In addi
tion, the 300-mg pregabalin group had a significantly longer duration of an
algesia than the ibuprofen group and had the highest score on the patient g
lobal impression of study medication. Adverse events were reported more fre
quently in the pregabalin 300-mg group.
Pregabalin appears to have significant analgesic properties in the third mo
lar extraction model. Further research is needed to confirm these findings.
(C) 2001 European federation of chapters of the International Association
for the study of Pain.