Title

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

UMMS Affiliation

Department of Pediatrics, Division of Pediatric Gastroentrology

Publication Date

2017-09-14

Document Type

Article

Disciplines

Anesthesia and Analgesia | Pediatrics

Abstract

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.

DOI of Published Version

10.1213/ANE.0000000000002456

Source

Anesth Analg. 2017 Sep 14. doi: 10.1213/ANE.0000000000002456. Link to article on publisher's site

Journal/Book/Conference Title

Anesthesia and analgesia

Related Resources

Link to Article in PubMed

PubMed ID

28922236

Link to Full Text

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