Journal
JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY
Volume 35, Issue 1, Pages 147-152Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/ANA.0000000000000881
Keywords
child development; critical care outcomes; electroencephalography; hypnotics and sedatives; intensive care units; pediatric; neuropsychological tests
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The design and conduct of pediatric sedation studies in critically ill patients have been historically challenging due to the complexity of the pediatric intensive care unit environment and the difficulty of establishing equipoise. Clinical trials are important in advancing knowledge in this field, but there is a lack of such studies in the literature. Considering ground-level factors and system limitations is crucial for successful trial planning and execution.
The design and conduct of pediatric sedation studies in critically ill patients have historically been challenging due to the complexity of the pediatric intensive care unit (PICU) environment and the difficulty of establishing equipoise. Clinical trials, for instance, represent 1 important means of advancing our knowledge in this field, but there is a paucity of such studies in the literature. Accounting for ground-level factors in planning for each trial phase (eg, enrollment, intervention, assessment, and follow-up) and the presence of broader system limitations is of key importance. In addition, there is a need for early planning, coordination, and obtaining buy-in from individual study sites and staff to ensure success, particularly for multicenter studies. This review synthesizes the current state of pediatric sedation research and the myriad of challenges in designing and conducting successful trials in this particular area. The review poses consideration for future research directions, including novel study designs, and discusses electroencephalography monitoring and neurodevelopmental outcomes of PICU survivors.
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