Dexmedetomidine non-inferior to midazolam for sedation in Mechanically Ventilated Children: Study

In children, dexmedetomidine has been reported to be an effective sedative agent without much side effects compared to benzodiazepines or opioids with the additional advantage of reducing the dose of conventional sedative agents. Though use of dexmedetomidine in mechanically ventilated children has increased over last few years, there is wide variation in practice regarding the dose and duration of the drug.

However, few trials that exist, evaluating the efficacy of dexmedetomidine as a sedative agent in mechanically ventilated children, have several limitations. Hence, Krishna Mohan Gulla and colleagues from the Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India conducted this noninferiority trial with an objective to compare dexmedetomidine with midazolam for adequacy of 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

The authors conducted an open label, non-inferiority, randomized controlled trial among 49 children who were randomized into two groups: 24 to 'midazolam group' and 25 to 'dexmedetomidine group' and the doses were titrated to maintain target sedation score of 4 or 5 as measured by Penn State Children Hospital Sedation algorithm.

The following findings were noted-

7. 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].
8. The absolute difference in the percentage of time spent was -10.9% [SE (95% CI) 7.05: (-25.15 to 3.25)].
9. The lower end of 95% CI for the difference breached the non-inferiority limit of -20%.
10. Number of fentanyl boluses, duration of mechanical ventilation, ICU stay, and hospital stay were similar.
11. Four (17.4%) children in dexmedetomidine group developed persistent bradycardia.

Therefore, the authors concluded that "Non-inferiority of dexmedetomidine compared to midazolam for sedation in children on mechanical ventilation could not be established."