Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

Stephen A. Cooper, Paul J. Desjardins, Dennis C. Turk, Robert H. Dworkin, Nathaniel P. Katz, Henrik Kehlet, Jane C. Ballantyne, Laurie B. Burke, Eugene Carragee, Penney Cowan, Scott Croll, Raymond A. Dionne, John T. Farrar, Ian Gilron, Debra B. Gordon, Smriti Iyengar, Gary W. Jay, Eija A. Kalso, Robert D. Kerns, Michael P. McdermottSrinivasa N. Raja, Bob A. Rappaport, Christine Rauschkolb, Mike A. Royal, Märta Segerdahl, Joseph W. Stauffer, Knox H. Todd, Geertrui F. Vanhove, Mark S. Wallace, Christine West, Richard E. White, Christopher Wu

Research output: Contribution to journalReview article

Abstract

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

Original languageEnglish (US)
Pages (from-to)288-301
Number of pages14
JournalPain
Volume157
Issue number2
DOIs
StatePublished - Feb 1 2016

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Keywords

  • Acute pain
  • Assay sensitivity
  • Clinical trial methods
  • Proof-of-concept trials
  • Randomized clinical trials
  • Research design

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

Cite this

Cooper, S. A., Desjardins, P. J., Turk, D. C., Dworkin, R. H., Katz, N. P., Kehlet, H., Ballantyne, J. C., Burke, L. B., Carragee, E., Cowan, P., Croll, S., Dionne, R. A., Farrar, J. T., Gilron, I., Gordon, D. B., Iyengar, S., Jay, G. W., Kalso, E. A., Kerns, R. D., ... Wu, C. (2016). Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations. Pain, 157(2), 288-301. https://doi.org/10.1097/j.pain.0000000000000375