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

被引:14
作者
Williams, Mark R. [1 ]
Nayshtut, Michael [2 ]
Hoefnagel, Amie [3 ]
McKeown, Andrew [1 ]
Carlson, Douglas W. [4 ]
Cravero, Joseph [5 ]
Lightdale, Jenifer [6 ]
Mason, Keira P. [5 ]
Wilson, Stephen [7 ]
Turk, Dennis C. [8 ]
Dworkin, Robert H. [1 ,9 ,10 ]
Ward, Denham S. [1 ,11 ]
机构
[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, 601 Elmwood Ave,Box 604, Rochester, NY 14642 USA
[2] Robert Wood Johnson St Barnabas Hlth Syst, Dept Anesthesiol, Livingston, NJ USA
[3] Univ Florida, Dept Anesthesiol, Jacksonville, FL USA
[4] Washington Univ, St Louis Childrens Hosp, Div Pediat Hosp Med, St Louis, MO 63110 USA
[5] Boston Childrens Hosp, Dept Anesthesiol Perioperat & Pain Med, Boston, MA USA
[6] Univ Massachusetts, Sch Med, Dept Pediat, UMass Mem Childrens Med Ctr, Worcester, MA USA
[7] Cincinnati Childrens Hosp Med Ctr, Div Pediat Dent, Cincinnati, OH 45229 USA
[8] Univ Washington, Dept Anesthesiol & Pain Med, Seattle, WA 98195 USA
[9] Univ Rochester, Sch Med & Dent, Dept Neurol, Rochester, NY 14642 USA
[10] Univ Rochester, Sch Med & Dent, Dept Psychiat, Rochester, NY 14642 USA
[11] Tufts Sch Med, Dept Anesthesiol, Boston, MA USA
关键词
OF-MICHIGAN SEDATION; EMERGENCY-DEPARTMENT; PRESCHOOL-CHILDREN; INTRANASAL MIDAZOLAM; PATIENT SATISFACTION; OBJECTIVE MEASURES; PAIN MEASUREMENT; ANESTHESIA CARE; ADVERSE EVENTS; RECOVERY SCALE;
D O I
10.1213/ANE.0000000000002456
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
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.
引用
收藏
页码:956 / 967
页数:12
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