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Efficacy Outcome Measures for Pediatric Procedural Sedation Clinical Trials: An ACTTION Systematic Review

Williams Mark R. MBBS BSc; Nayshtut, Michael DO; Hoefnagel, Amie MD; McKeown, Andrew BS; Carlson, Douglas W. MD; Cravero, Joseph MD; Lightdale, Jenifer MD, MPH; Mason, Keira P. MD; Wilson, Stephen DMD, PhD; Turk, Dennis C. PhD; Dworkin, Robert H. PhD; Ward, Denham S. MD, PhD
doi: 10.1213/ANE.0000000000002456
Research Report: PDF Only

Objective evaluations comparing different techniques and approaches to pediatric procedural sedation studies have been limited by a lack of consistency among the outcome measures used in assessment. This study reviewed those existing measures, which have undergone psychometric analysis in a pediatric procedural sedation setting, to determine to what extent and in what circumstances their use is justified across the spectrum of procedures, age groups, and techniques. The results of our study suggest that a wide range of measures has been used to assess the efficacy and effectiveness of pediatric procedural sedation. Most lack the evidence of validity and reliability that is necessary to facilitate rigorous clinical trial design, as well as the evaluation of new drugs and devices. A set of core pediatric sedation outcome domains and outcome measures can be developed on the basis of our findings. We believe that consensus among all stakeholders regarding appropriate domains and measures to evaluate pediatric procedural sedation is possible and that widespread implementation of such recommendations should be pursued.

Accepted for publication July 25, 2017.

Funding: Financial support for this project was provided by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public–private partnership, which has received research contracts, grants, or other revenue from the United States Food and Drug Administration, multiple pharmaceutical and device companies, and other sources.

The authors declare no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.anesthesia-analgesia.org).

Reprints will not be available from the authors.

Address correspondence to Denham S. Ward, MD, PhD, Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Box 604, Rochester, NY 14642. Address e-mail to Denham_Ward@URMC.Rochester.edu.

© 2017 International Anesthesia Research Society

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