Efficacy and safety of dexmedetomidine versus midazolam for sedation in mechanically ventilated pediatric patients: a randomized clinical trial.

Abstract

Aims: The benefits of Dexmedetomidne in sedation of mechanically ventilated pediatric patients are still challenging. In this study, we compared the efficacy and safety of Dexmedetomidine versus Midazolam for achieving deep sedation in pediatric patients receiving mechanical ventilation.

Methods: A randomized clinical trial was conducted across three affiliated hospitals during February 2023 until February 2024. Eligible mechanically ventilated children aged 1 month to 18 years were randomized 1:1 to receive either Dexmedetomidine (0.25-1 mcg/kg/h) or midazolam (1-4 mcg/kg/min) for sedation, alongside fentanyl analgesia. Sedation was assessed using the Ramsey Sedation Scale and target scores set on 5-6. Primary outcomes included success rates in achieving target sedation at the beginning of mechanical ventilation; secondary outcomes encompassed hemodynamic adverse effects (hypotension, bradycardia), follow-up assessment of sedation level of successful patients over the next 6 h, mortality rate, mean arterial blood pressures and heart rates (HR) changes, mechanical ventilation and PICU stay duration.

Main results: Among 130 eligible patients, 120 were analyzed after exclusions (60 per group). Demographic characteristics were similar between groups. The primary outcome revealed that Dexmedetomidine was less effective than Midazolam in achieving target sedation levels across all ages (p < 0.001). In infants under one year, there was no significant difference in sedation effectiveness between the two medications (P = 0.157). Notably, Dexmedetomidine patients required higher drug doses to maintain sedation over 6 h, while Midazolam patients experienced fewer adjustments (p < 0.001). Hemodynamic complications were significantly less frequent in the Dexmedetomidine group (3.3% vs. 23.3% for hypotension; p < 0.01). However, the two groups did not differ in terms of MAP and HR changes (P = 0.255; P = 0.063). Mortality, mechanical ventilation duration and length of PICU stay were not different between two groups (P = 0.853; P = 0.076; P = 0.082).

Conclusion: Dexmedetomidine is inferior to Midazolam for deep sedation during mechanical ventilation in children aged 1 month to 18 years. However, it can be effective in infants under one year of age. Dexmedetomidine presents a lower risk of hemodynamic side effects compared to Midazolam.

Trial registration: IRCT20190522043672N3 on February 16, 2023.