Considerations in the Design and Analysis of Postoperative Dental Pain Studies

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.