Abstract
The single-dose, postoperative dental pain impaction pain model initially was used for 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 and/or 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 and/or 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 single-dose studies.
Similar content being viewed by others
References
Lökken P, Olsen I, Bruaset I, Norman-Perdersen K. Bilateral surgical removal of impacted lower third molar teeth as a model for drug evaluation: a test with ibuprofen. Europ J Clin Pharmacol. 1975;8:209–216.
Cooper SA, Beaver WT. A model to evaluate mild analgesics in oral surgery outpatients. Clin Pharmacol Ther. 1976;20:241–250.
United States Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for the clinical evaluation of analgesic drugs. Rockville, MD: United States Department of Health and Human Services; December 1992.
Cooper SA. Single-dose analgesic studies: The upside and downside assay sensitivity. In: Max MB, Portenoy R, Laska EM, eds. Advances in Pain Research. Volume 18. New York, NY: Raven Press; 1991:117–124.
Morrison BW, Christensen S, Yuan W, Brown J, S, Seidenberg B. Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: a randomized controlled trial. Clin Ther. 1999;21:943–953.
Hersh EV, Levin LM, Cooper SA, Reynolds D, Gallegos LT, McGoldrick K, Appel A. Conventional and extended-release etodolac for postsurgical dental pain. Clin Ther. 1999;21:1333–1342.
Forbes JA. Oral surgery. In: Max MB, Portenoy R, Laska EM, eds. Advances in Pain Research. Volume 18. New York, NY: Raven Press; 1991:347–374.
United States Food and Drug Administration, Center for Drug Evaluation and Research. Presentation of efficacy results of single-dose analgesics for studies using acute pain models. Rockville, MD: United States Department of Health and Human Services; January 1997.
Silverman DG, O’Connor TZ, Brull SJ. Integrated assessment of pain scores and rescue morphine use during studies of analgesic efficacy. Anesth Analg. 1993;77:168–170.
Stambaugh JE, McAdams J. Comparison of intramuscular dezocine with butorphanol and placebo in chronic cancer pain: A method to evaluate analgesia after both single and repeated doses. Pharmacol Ther. 1987;42:210–219.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Edelman, D.A., Loose, L.D. Considerations in the Design and Analysis of Postoperative Dental Pain Studies. Ther Innov Regul Sci 36, 481–485 (2002). https://doi.org/10.1177/009286150203600301
Published:
Issue Date:
DOI: https://doi.org/10.1177/009286150203600301