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J Pain. 2019 Apr;20(4):394-404. doi: 10.1016/j.jpain.2018.08.007. Epub 2018 Sep 13.

Design and Reporting Characteristics of Clinical Trials of Select Chronic and Recurrent Pediatric Pain Conditions: An Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks Systematic Review.

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Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York.
Department of Anesthesiology, Perioperative and Pain Medicine, Stanford Children's Health and Stanford University, Stanford, California.
Department of Neurology, Boston Children's Hospital, Boston, Massachusetts.
Department of Anesthesiology, Seattle Children's Hospital, Seattle, WA and University of Washington School of Medicine, Seattle, Washington.
Department of Anesthesiology, Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, Seattle, Washington.
Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York.. Electronic address:


Fewer randomized clinical trials (RCTs) are conducted for chronic or recurrent pain in pediatric populations compared with adult populations; thus, data to support treatment efficacy in children are limited. This article evaluates the design features and reporting practices of RCTs for chronic and recurrent pain that are likely unique to, or particularly important in, a pediatric population to promote improvements in the evidence base for pediatric pain treatments. Areas covered include outcome measure selection and reporting and reporting of adverse events and challenges to recruitment and retention. A search of PubMed and EMBASE identified primary publications describing RCTs of treatments for select chronic and recurrent pain conditions in children or adolescents published between 2000 and 2017. Only 49% of articles identified a primary outcome measure. The primary outcome measure assessed pain intensity in 38% of the trials, specifically measure by verbal rating scale (13%), faces pain scale (11%), visual analogue scale (9%), or numeric rating scale (5%). All of the CONSORT harms reporting recommendations were fulfilled by <50% of the articles. Discussions of recruitment challenges occurred in 64% of articles that enrolled <90% of their target sample. However, discussions regarding retention challenges only occurred in 14% of trials in which withdrawal rates were >10%. The goal of this article is to promote comprehensive reporting of pediatric pain RCTs to improve the design of future trials, facilitate conduction of systematic reviews and meta-analyses, and better inform clinical practice. PERSPECTIVE: This review of chronic and recurrent pediatric pain trials demonstrates inadequacies in the reporting quality of key features specifically important to pediatric populations. It provides recommendations that address these shortcomings to promote continued efforts toward improving the quality of the design and publication of future pediatric clinical pain trials.


Pediatric pain; clinical trials; reporting

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