Abstract
The intradermal capsaicin pain model has been used to evaluate analgesic effects of
a variety of drugs. Using the sequential up-down method, we examined the analgesic
effects of pregabalin on intradermal capsaicin pain. Using a double-blind, placebo-controlled,
crossover study, healthy adult men were randomized to oral pregabalin or placebo on
the first visit and returned for the opposite treatment after a washout period. Dosing
was set by the Dixon sequential up-down method; that is, a greater or less than 30%
reduction in capsaicin pain decreased or increased the dose, respectively, by a fixed
interval for the next subject. The median effective dose (ED50) was derived once 7
changes in dose direction occurred. Secondary outcome measures included secondary
hyperalgesia and tactile and thermal allodynia, and their respective areas (cm2). Thirteen subjects were required to derive the pregabalin ED50: 252 mg (95% confidence
interval 194, 310 mg). Most common side effects were drowsiness (46%), euphoria (31%),
and dizziness (7%). Those with ≥30% pain reduction as compared to placebo also had
similar reductions in secondary outcome measures. The intradermal capsaicin pain model
can be used to efficiently derive the pregabalin ED50, but well-powered dose-response
curve studies are needed for comparison and validation.
Perspective
Using the Dixon sequential up-down method, the ED50 of pregabalin on intradermal capsaicin
induced pain was successfully calculated (252 mg) using only 13 subjects.
Key words
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Article info
Publication history
Published online: November 21, 2013
Accepted:
August 28,
2013
Received in revised form:
August 13,
2013
Received:
April 4,
2013
Footnotes
This study was partially funded by a research grant from Pfizer.
The authors declare no conflict of interests.
Identification
Copyright
© 2014 American Pain Society. Published by Elsevier Inc. All rights reserved.
