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

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."