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Current methods and challenges for acute pain clinical trials

Gilron, Iana,b,*; Carr, Daniel B.c; Desjardins, Paul J.d; Kehlet, Henrike

doi: 10.1097/PR9.0000000000000647
ACTTION Special Issue on Clinical Trials of Pain Treatments: PDF Only

Introduction: The clinical setting of acute pain has provided some of the first approaches for the development of analgesic clinical trial methods.

Objectives: This article reviews current methods and challenges and provides recommendations for future design and conduct of clinical trials of interventions to treat acute pain.

Conclusion: Growing knowledge about important diverse patient factors as well as varying pain responses to different acute pain conditions and surgical procedures has highlighted several emerging needs for acute pain trials. These include development of early-phase trial designs that minimize variability and thereby enhance assay sensitivity, minimization of bias through blinding and randomization to treatment allocation, and measurement of clinically relevant outcomes such as movement-evoked pain. However, further improvements are needed, in particular for the development of trial methods that focus on treating complex patients at high risk of severe acute pain.

This is an open access article distributed under the Creative Commons Attribution-NoDerivatives License 4.0 (CC BY-ND) which allows for redistribution, commercial and non-commercial, as long as it is passed along unchanged and in whole, with credit to the author.

This article reviews current methods and challenges and provides recommendations for future design and conduct of clinical trials of interventions to treat acute pain.

Departments of aAnesthesiology and Perioperative Medicine and

bBiomedical and Molecular Sciences, Queen's University, Kingston, ON, Canada

cPain, Research Education and Policy Program, Public Health and Community Medicine Program, Tufts University School of Medicine, Boston, MA, USA

dDesjardins Associates, Maplewood, NJ, USA

eSection for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark

Corresponding author. Address: Department of Anesthesiology, Queen's University, 76 Stuart St, Kingston, ON K7L 2V7, Canada. Tel.: 613-548-7827; fax: 613-548-1375. E-mail address: gilroni@queensu.ca (I. Gilron).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Received August 28, 2017

Received in revised form January 16, 2018

Accepted January 31, 2018

© 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.