J Clin Pharmacol
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CLINICAL STUDIES

Dental Impaction Pain Model as a Potential Tool to Evaluate Drugs With Efficacy in Neuropathic Pain

Kerstin Malmstrom, PhD, Paul Kotey, PhD, Megan McGratty, RN, Rohini Ramakrishnan, PhD, Keith Gottesdiener, MD, Alise Reicin, MD and John A. Wagner, MD, PhD

From the Departments of Clinical Immunology & Analgesia, Clinical Pharmacology, and Biostatistics, Merck Research Laboratories, Rahway, New Jersey, and Clinical Drug Metabolism, West Point, Pennsylvania.

Intravenous lidocaine, a nonspecific Na-channel blocker, was used to assess the dental impaction model for evaluation of neuropathic pain drugs. Sixty patients, experiencing moderate or severe pain after removal of ≥ 2 third molars, were randomized (2:2:1:1) to lidocaine (4 mg/kg; maximal dose 300 mg), oxycodone/acetaminophen (10/650 mg), placebo, and active placebo (diphenhydramine, 50 mg). Lidocaine provided a modest degree of pain relief. Predefined endpoints of total pain relief and sum of pain intensity at 2, 4, and 6 hours showed numerically, not statistically significantly, greater pain relief versus placebo. A significantly greater effect over placebo was observed in peak effect and at shorter time points (30 minutes and 1 hour), consistent with the pharmacokinetic profile (plasma concentration of ~2 µg/mL). Oxycodone/acetaminophen provided significantly greater analgesia versus placebo, validating study conduct, and significantly greater pain relief was observed versus lidocaine, which is consistent with a smaller portion of dental extraction pain being of neuropathic origin.

Key Words: Neuropathic pain • dental impaction pain • lidocaine • pain model


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