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 published in JAMA.
The study is being released to coincide with its presentation at the Annual Meeting of the Society of Critical Care Medicine (SCCM).
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 paediatric critical care and knowledge generated in adult critical care may not translate to the care of critically ill children.
For the current study, Martha A.Q. Curley, PhD, University of Pennsylvania, Philadelphia, Pennsylvania, and colleagues examined 2,449 children (mean age, 4.7 years) mechanically ventilated for acute respiratory failure who were randomised to a sedation intervention (17 sites; n = 1,225 patients) or sedation with usual care (14 sites; n = 1,224 patients).
The intervention included targeted sedation, arousal assessments, extubation 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 was conducted from 2009-2013.
The duration of mechanical ventilation — the primary outcome for the study — was not different between the 2 groups (median 6.5 days for both groups). There were no group differences in the time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, intensive care unit (ICU) 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.
Patients in the intervention group experienced more post-extubation stridor (7% vs 4%) and fewer stage 2 or worse immobility-related pressure ulcers (<1% vs 2%).
“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 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 wrote.
The researchers noted that although their 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,” the authors wrote.
In an accompanying editorial, Sangeeta Mehta, MD, Mount Sinai Hospital and the University of Toronto, Toronto, Ontario, wrote: “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. 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 paediatric ICUs were not significantly different than protocoled sedation in the intervention paediatric ICUs. 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.”