Highlights
- •Reported primary outcome measures were highly variable between trials.
- •CONSORT adverse event reporting standards were met in <50% of the articles reviewed.
- •Reporting recommendations for chronic pediatric pain trials are provided.
Abstract
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.
Key words
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Article info
Publication history
Published online: September 13, 2018
Footnotes
M.R.C. and J.Y.C contributed equally to this work
Disclosures: Financial support for this project was provided by the ACTTION public–private partnership, which has received research contracts, grants, or other revenue from the US Food and Drug Administration (FDA), multiple pharmaceutical and device companies, philanthropy, and other sources. The views expressed in this article are those of the authors and no official endorsement by the FDA or the pharmaceutical and device companies that provided unrestricted grants to support the activities of the ACTTION public–private partnership should be inferred.
The authors have no conflicts of interest to disclose related to the subject matter of this article.
Supplementary data accompanying this article are available online at www.jpain.org and www.sciencedirect.com.
Identification
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© Published by Elsevier Inc. on behalf of the American Pain Society
