Efficacy of Dexmedetomidine compared to Midazolam for sedation in mechanically ventilated patients in Pediatric Intensive Care Unit- A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Efficacy of sedation
Study Overview
Brief Summary
We wish to test the efficacy of dexmedetomidine vs midazolam infusions for sedation of mechanically ventilated children in PICU, JIPMER. All children who meet inclusion criteria, after consent, will be started on either dexmedetomidine or midazolam infusion for sedation, and infusions will be prepared in such a way that dosing range will be 0.3-1.5 mcg/kg/hour for dexmedetomidine, and 1-5 mcg/kg/min for midazolam. Infusions will be prepared in such a way that this will correspond to 1-5 ml/hour rate for both drugs. Investigator, participants and outcome assessors will be blinded. Efficacy of sedation will be assessed using sedation scores every 6 hourly, and assessing the proportion of measurements, out of total measurements, when child was in adequate sedation. Means of the proportion between the two groups will be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 1.00 Month(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Mechanically ventilated children in PICU.
Exclusion Criteria
- •Children with raised intracranial pressure, HIE sequelae, refractory shock, bradycardia.
Outcomes
Primary Outcomes
Efficacy of sedation
Time Frame: 5 days
Secondary Outcomes
- Delirium, Bolus doses of sedoanalgesia, iatrogenic withdrawal syndrome, adverse effects(5 days)
Investigators
Narayanan P
Professor, Pediatrics
