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Clinical Trials/CTRI/2024/11/076689
CTRI/2024/11/076689Not yet recruitingPhase 3

Efficacy of Dexmedetomidine compared to Midazolam for sedation in mechanically ventilated patients in Pediatric Intensive Care Unit- A Randomized Controlled Trial

Intramural research funds JIPMER1 site in 1 country180 target enrollmentStarted: November 18, 2024Last updated:

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

Sponsor
Intramural research funds JIPMER
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Narayanan P

Professor, Pediatrics

Study Sites (1)

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