A Randomised controlled trial to compare safety and efficacy of dexmedetomidine versus midazolam continuous infusion for sedation in mechanically ventilated children

Sedation is an essential component of care for children requiring invasive mechanical ventilation in the Paediatric Intensive Care Unit (PICU). Adequate sedation improves patient comfort, facilitates ventilator synchrony, and prevents complications such as accidental extubation. Midazolam, a benzodiazepine, is commonly used for sedation but is associated with adverse effects including respiratory depression, tolerance, and withdrawal. Dexmedetomidine, an alpha-2 adrenergic agonist, provides effective sedation with minimal respiratory depression but may cause hemodynamic effects such as bradycardia and hypotension.

This study is designed to compare the efficacy and safety of dexmedetomidine versus midazolam infusion for sedation in mechanically ventilated children admitted to the PICU. It is an open-label randomized controlled trial conducted at a tertiary care teaching hospital. Children aged 1 month to 14 years requiring invasive mechanical ventilation will be enrolled after obtaining written informed consent from parents or legally acceptable representatives.

Eligible participants will be randomized into two groups: one group will receive continuous infusion of dexmedetomidine and the other will receive continuous infusion of midazolam. Sedation will be assessed using the Penn State Children’s Hospital Sedation Algorithm, and drug doses will be titrated to achieve the target sedation level.

The primary outcome is the percentage of time spent in the target sedation range. Secondary outcomes include duration of mechanical ventilation, length of PICU stay, and incidence of adverse effects such as bradycardia, hypotension, and respiratory depression.

The results of this study will help determine the optimal sedative agent for mechanically ventilated children in the PICU and contribute to evidence-based sedation practices in the pediatric critical care setting.