Dexmedetomidine versus midazolam for sedation in mechanically ventilated children: a randomized controlled trial

Abstract

Objectives: To compare the efficacy of dexmedetomidine and midazolam for sedation of mechanically ventilated children admitted to PICU. Secondary objectives were to compare the top up doses of fentanyl and paralytic agents, length of mechanical ventilation, ICU stay and hospital stay, and adverse events. Materials and methods: An open label, non inferiority RCT was done from August 2016 to April 2018 in PICU of a tertiary care hospital in India. Sedation level was assessed using Penn State Children Hospital sedation algorithm and the targeted sedation was 4 or 5 score. Maximum dose of midazolam was 4 mcg/kg/min and of dexmedetomidine was 0.75 mcg/kg/hr. Sum of the periods (in hours) the patient was monitored for sedation, the time periods (in hours) where the patient was at level of sedation 4 or 5 were calculated. Percentage of time spent in level 4 or 5 was calculated. Results: 49 children were randomized (24 in midazolam and 25 in dexmedetomidine). 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 between the groups was -10.94% [(SE=7.05); 95% CI: -25.15 to 3.25]. The lower end of 95% CI for this difference breached the non-inferiority limit of -20%. Number of fentanyl boluses, duration of mechanical ventilation, ICU stay and hospital stay were similar between the groups. Four (17.4%) children in dexmedetomidine group developed persistent bradycardia, while none in midazolam group (p=0.05). Conclusion: Our study could not establish the non-inferiority of dexmedetomidine compared to midazolam for sedation in children on mechanical ventilation.