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Special considerations in conducting clinical trials of chronic pain management interventions in children and adolescents and their families

Palermo, Tonya M.a,b,*; Kashikar-Zuck, Susmitac,d; Friedrichsdorf, Stefan J.e; Powers, Scott W.c,d

doi: 10.1097/PR9.0000000000000649
ACTTION Special Issue on Clinical Trials of Pain Treatments: PDF Only

Introduction: Disabling chronic pain is a common experience for children and adolescents. However, the evidence base for chronic pain interventions for youth is extremely limited, which has hindered the development of evidence-based practice guidelines for most pediatric chronic pain conditions.

Objectives: To review and provide recommendations on clinical trial design and evaluation in children and adolescents with chronic pain.

Methods: In this article, we summarize key issues and provide recommendations for addressing them in clinical trials of chronic pain interventions in children and adolescents and their families.

Results: To stimulate high-quality trials of pediatric chronic pain management interventions, attention to key issues including sample characterization, trial design and treatment administration, outcome measurement, and the ethics of intervening with children and adolescents, as opposed to adults with chronic pain, is needed.

Conclusion: Future research to develop interventions to reduce or prevent childhood chronic pain is an important priority area, and requires special considerations in implementation and evaluation in clinical trials.

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

aCenter for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA

bDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA

cDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA

dDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA

eDepartment of Pain Medicine, Palliative Care and Integrative Medicine, Children's Hospitals and Clinics of Minnesota, Minneapolis, MN, USA

Corresponding author. Address: Seattle Children's Research Institute, M/S CW8-6, PO Box 5371, Seattle, WA 98145-5005. Tel.: 1-206-884-4208; fax: 206-985-3262. E-mail address: (T.M. Palermo).

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

Received November 30, 2017

Received in revised form February 21, 2018

Accepted March 03, 2018

© 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.