Dexmedetomidine vs Midazolam for Sedation in Mechanically Ventilated Children: A Randomized Controlled Trial.

BACKGROUND There is a paucity of data on use of dexmedetomidine as a sedative agent in mechanically ventilated children. OBJECTIVES To compare the efficacy of dexmedetomidine and midazolam for sedation in mechanically ventilated children aged 1 month - 15 years. Secondary objectives were to compare the need for top-up doses of fentanyl and paralytic agents, duration of mechanical ventilation, ICU stay and hospital stay, and adverse events. DESIGN Open label, non-inferiority, randomized controlled trial. SETTING PICU of a tertiary care teaching hospital in India. PATIENTS Consecutive children aged 1 month to 15 years who were mechanically ventilated. INTERVENTION Children were randomized to either dexmedeto-midine or midazolam and the doses were titrated to maintain target sedation score of 4 or 5 as measured by Penn State Children Hospital Sedation algorithm. OUTCOME The percentage of time spent in level 4 or 5 of Penn State Children Hospital sedation algorithm for ventilated children. RESULTS 49 children were randomized (24 to 'midazolam group' and 25 to 'dexmedetomidine group'). There was no difference in the percentage of time spent in the targeted sedation between the groups [midazolam 67.3% (18.8) vs. dexmedetomidine 56.3 %. (28.6); P=0.12]. The absolute difference in the percentage of time spent was -10.9% [SE (95% CI) 7.05: (-25.15 to 3.25)]. The lower end of 95% CI for the difference breached the non-inferiority limit of -20%. Number of fentanyl boluses, duration of mechanical ventilation, ICU stay, and hospital stay were similar. Four (17.4%) children in dexmedetomidine group developed persistent bradycardia. CONCLUSION Non-inferiority of dexmedetomidine compared to midazolam for sedation in children on mechanical ventilation could not be established.