Open Access Study protocol

Daily interruption of sedation in critically ill children: study protocol for a randomized controlled trial

Nienke J Vet12*, Saskia N de Wildt13, Carin WM Verlaat4, Catherijne AJ Knibbe56, Miriam G Mooij13, Wim CJ Hop7, Joost van Rosmalen7, Dick Tibboel13, Matthijs de Hoog12 and on behalf of SKIC (Dutch collaborative PICU research network)

Author Affiliations

1 Intensive Care, Erasmus MC - Sophia Children’s Hospital, Dr. Molewaterplein 60, 3015 GJ Rotterdam, The Netherlands

2 Department of Pediatrics, Erasmus MC - Sophia Children’s Hospital, Rotterdam, The Netherlands

3 Department of Pediatric Surgery, Erasmus MC - Sophia Children’s Hospital, Rotterdam, The Netherlands

4 Intensive Care, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

5 Department of Pharmacology, Leiden/Amsterdam Center for Drug Research, Leiden University, Leiden, The Netherlands

6 Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands

7 Department of Biostatistics, Erasmus MC, Rotterdam, The Netherlands

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Trials 2014, 15:55  doi:10.1186/1745-6215-15-55

Published: 13 February 2014

Abstract

Background

In adult patients who are critically ill and mechanically ventilated, daily interruption of sedation (DSI) is an effective method of improving sedation management, resulting in a decrease of the duration of mechanical ventilation, the length of stay in the intensive care unit (ICU) and the length of stay in the hospital. It is a safe and effective approach and is common practice in adult ICUs. For critically ill children it is unknown if DSI is effective and feasible. The aim of this multicenter randomized controlled trial is to evaluate the safety and efficacy of daily sedation interruption in critically ill children.

Methods/Design

Children between 0 and 18 years of age who require mechanical ventilation, with an expected duration of at least 48 h and need for sedative infusion, will be included. After enrollment patients will be randomly assigned to DSI in combination with protocolized sedation (intervention group) or protocolized continuous sedation (control group). A sedation protocol that contains an algorithm for increasing and weaning of sedatives and analgesics will be used. The sedative infusion will be restarted if the patient becomes uncomfortable or agitated according to the sedation protocol. The primary endpoint is the number of ventilator-free days at 28 days.

Trial registration

NTR2030

Keywords:
Pediatrics; Critical illness; Sedation; Daily sedation interruption