Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation

Autor: Edmund H. Jooste, Gregory B. Hammer, Christian R. Reyes, Vaibhav Katkade, Peter Szmuk
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: Frontiers in Pharmacology, Vol 8 (2017)
Druh dokumentu: article
ISSN: 1663-9812
DOI: 10.3389/fphar.2017.00529
Popis: Dexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Patients received one of two doses dependent on age: patients aged ≥28 weeks' gestational age to
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