Efficacy and safety of dexmedetomidine for prevention of withdrawal syndrome in the pediatric intensive care unit: protocol for an adaptive, multicenter, randomized, double-blind, placebo-controlled, non-profit clinical trial

Autor:	Maria Cristina Mondardini, Francesca Sperotto, Marco Daverio, Fabio Caramelli, Dario Gregori, Maria Francesca Caligiuri, Francesca Vitale, Maria Teresa Cecini, Marco Piastra, Aldo Mancino, Andrea Pettenazzo, Giorgio Conti, Angela Amigoni
Jazyk:	angličtina
Rok vydání:	2019
Předmět:	Dexmedetomidine Analgesia Sedation Withdrawal syndrome Abstinence syndrome Pediatric intensive care unit Medicine (General) R5-920
Zdroj:	Trials, Vol 20, Iss 1, Pp 1-9 (2019)
Druh dokumentu:	article
ISSN:	1745-6215
DOI:	10.1186/s13063-019-3793-6
Popis:	Abstract Background Prolonged treatment with analgesic and sedative drugs in the pediatric intensive care unit (PICU) may lead to undesirable effects such as dependence and tolerance. Moreover, during analgosedation weaning, patients may develop clinical signs of withdrawal, known as withdrawal syndrome (WS). Some studies indicate that dexmedetomidine, a selective α2-adrenoceptor agonist, may be useful to prevent WS, but no clear evidence supports these data. The aims of the present study are to evaluate the efficacy of dexmedetomidine in reducing the occurrence of WS during analgosedation weaning, and to clearly assess its safety. Methods We will perform an adaptive, multicenter, randomized, double-blind, placebo-controlled trial. Patients aged
Databáze:	Directory of Open Access Journals
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