Abstract

IMPORTANCE Protocolized sedation improves clinical outcomes in critically ill adults, but its effect in children is unknown. OBJECTIVE To determine whether critically ill children managed with a nurse-implemented, goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized trial conducted in 31 US pediatric intensive care units. A total of 2449 children mechanically ventilated for acute respiratory failure were enrolled in 2009-2013 and followed up until 72 hours after opioids were discontinued, 28 days, or hospital discharge. INTERVENTION Intervention PICUs used a protocol that included targeted sedation, arousal assessments, extubation readiness testing, sedation adjustment every 8 hours, and sedation weaning. Control PICUs managed sedation per usual care. MAIN OUTCOMES AND MEASURES The primary outcomewas duration of mechanical ventilation. Secondary outcomes included time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, neurological testing, PICU and hospital lengths of stay, in-hospital mortality, sedation-related adverse events, measures of sedative exposure, and occurrence of iatrogenic withdrawal. RESULTS Duration of mechanical ventilationwas not different between the 2 groups. Sedation-related adverse events including inadequate pain and sedation management, clinically significant iatrogenic withdrawal, and unplanned endotracheal tube/invasive line removalwere not significantly different between the 2 groups. Intervention patients experienced more postextubation stridor and fewer stage 2 orworse immobility-related pressure ulcers. In exploratory analyses, intervention patients had fewer days of opioid administration,were exposed to fewer sedative classes, andwere more often awake and calm while intubated than control patients, respectively; however, intervention patients had more days with any report of a pain score 4 and any report of agitation, respectively. CONCLUSIONS AND RELEVANCE Among children undergoing mechanical ventilation for acute respiratory failure, the use of a sedation protocol compared with usual care did not reduce the duration of mechanical ventilation. Exploratory analyses of secondary outcomes suggest a complex relationship among wakefulness, pain, and agitation.