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Use of sedation protocol does not reduce time on ventilator for children

The JAMA Network Journals

Among children undergoing mechanical ventilation for acute respiratory failure, the use of a nurse-implemented, goal­directed sedation protocol compared with usual care did not reduce the duration of mechanical ventilation, according to a study appearing in JAMA. The study is being released to coincide with its presentation at the Society of Critical Care Medicine's 44th Critical Care Congress.

Although sedation therapy benefits critically ill infants and children, it is also associated with adverse effects. Numerous studies in adult critical care support a minimal yet effective approach to sedation management. In contrast, few data inform sedation practices in pediatric critical care. Knowledge generated in adult critical care may not translate to the care of critically ill children, according to background information in the article.

Martha A.Q. Curley, R.N., Ph.D., of the University of Pennsylvania, Philadelphia, and colleagues studied 2,449 children (average age, 4.7 years) mechanically ventilated for acute respiratory failure in pediatric intensive care units (PICUs) to a sedation intervention (17 sites; n = 1,225 patients) or sedation with usual care (14 sites; n = 1,224 patients). The intervention PICUs used a protocol that included targeted sedation, arousal assessments, extubation (removal of breathing tube) readiness testing, sedation adjustment every 8 hours, and sedation weaning. Patients were followed up until 72 hours after opioids were discontinued, 28 days, or hospital discharge. The study (RESTORE) was conducted from 2009-2013.

The duration of mechanical ventilation, the primary outcome for the study, was not different between the 2 groups (intervention: median, 6.5 days vs control: median, 6.5 days). There were no group differences in the time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, PICU and hospital lengths of stay or 28- or 90-day in-hospital mortality. There were no significant differences in sedation-related adverse events including inadequate pain management, inadequate sedation management, extubation failure, ventilator-associated pneumonia, catheter-associated bloodstream infection, or new tracheostomy. Intervention patients experienced more postextubation stridor (an abnormal sound made when the breathing passages are narrowed; 7 percent vs 4 percent) and fewer stage 2 or worse immobility-related pressure ulcers (<1 percent vs 2 percent).

"Exploratory analyses of several secondary outcomes indicated that the sedation protocol was associated with a difference in patients' sedation experience; patients in the intervention group were able to be safely managed in a more awake and calm state while intubated, receiving fewer days of opioid exposure and fewer sedative classes without an increase in inadequate pain or sedation management or clinically significant iatrogenic [consequence of treatment] withdrawal compared with patients receiving usual care, but they experienced more days with reported pain and agitation, suggesting a complex relationship among wakefulness, pain, and agitation," the authors write.

The researchers add that although this study focused on the process of how sedatives are administered, future studies should compare the best sedative agent for varied lengths of critical illness. "Outcomes of interest include efficacy as well as an evaluation of the immediate risk-benefit ratio and an evaluation of the long-term effect of sedatives on neurocognitive development and posttraumatic stress."

"Curley and colleagues answered the call for the conduct of a large clinical trial in children and have contributed valuable data to help advance approaches to sedation management in critically ill children," writes Sangeeta Mehta, M.D., F.R.C.P.C., of Mount Sinai Hospital and the University of Toronto, in an accompanying editorial.

"While it is disappointing that this trial showed no advantage of a complex sedation management strategy, it is reassuring that the overall clinical outcomes related to 'usual care' in the 14 control PICUs were not significantly different than protocolized sedation in the intervention PICUs. It is imperative that high-quality research in this field continues, not only to learn more about the short- and long-term effects of sedation strategies but, more importantly, to improve clinical care and outcomes for these vulnerable patients."


doi:10.1001/jama.2014.18399; Available pre-embargo to the media at

The study was supported by grants from the National Heart, Lung, and Blood Institute and the National Institute of Nursing Research, National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

Editorial: Protocolized Sedation in Critically Ill Children

doi:10.1001/jama.2015.1; Available pre-embargo to the media at

Editor's Note: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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