Considerations in the Design and Analysis of Postoperative Dental Pain Studies
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0092-86 IS/2002
Printed in Ihe USA All rights reserved.
Copyright 0 2002 Drug Information Association Inc.
CONSIDERATIONS IN THE DESIGN AND ANALYSIS OF POSTOPERATIVE DENTAL PAIN STUDIES DAVIDA. EDELMAN, PHD Medical Research Consultants, Inc.. San Diego, California
LELANDD. LOOSE,PHD Pfizer, Inc., Pfizer Central Research, Groton, Connecticut
The single-dose, postoperative dental pain impaction pain model initial1.v was used f o r the evaluation of short-acting analgesics. In recent years, this model has been extended to the evaluation of long-acting analgesics and analgesics intended for the treatment of acute andor chronic pain, and also has been modified to include a multiple-dose treatment period following the initial single-dose evaluation. These extensions have introduced potential biases andor confounding factors that may complicate the interpretation of the study results. Some of the design and analysis issues related to these extensions are discussed, including the appropriate comparisons in single-dose studies, and the choice of dosing regimen and which subjects to include in the multiple-dose extension of singledose studies. Key Words: Dental pain model; Analgesics; Multiple dose
INTRODUCTION IN 1975, LOKKEN AND co-workers (1) were among the first to report on the dental pain model for the evaluation of anti-inflammatory drugs. These researchers used a twoperiod crossover design in which an impacted third molar was removed in the first period and an ipsilateral impacted third molar was removed in the second period. Pain and other efficacy assessments were performed after the removal of each molar. This study design is impractical since it requires two surgical procedures for each subject. The dental pain model that presently is in common use for the evaluation of analgesic agents was first described by Cooper and
Reprint address: David A. Edelman. PhD, Medical Research Consultants. Inc.. 4317 Alder Drive, San Diego, CA 921 16.
Beaver in 1976 (2). Since that time refinements have been made to the study procedures, methods of data collection, and study analyses. The postoperative dental pain impaction pain model has proven to be a sensitive and excellent one for the evaluation of centrallyand peripherally-acting analgesics, in terms of describing their onset and duration of effect and peak effects (3,4). This pain model is particularly attractive to researchers since studies using this model can be rapidly completed as there is ample availability of patients who require extraction of their third molars, and the duration of patient followup is short. Also, as initially conceived, these studies can be conducted in an outpatient setting. The dental pain model initially was used for the evaluation of short-acting analgesics intended for the treatment of acute pain, and
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David A. Edelmun and Leland D. Loose
usually required the recording of efficacy assessments over a six- to eight-hour period after dosing. In recent years, t
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