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Efficacy of dexmedetomidine versus midazolam plus fentanyl for sedation in intubated children

Efficacy of dexmedetomidine versus midazolam plus fentanyl for sedation in mechanically ventilated children - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093256
Enrollment
100
Registered
2025-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z991- Dependence on respirator

Interventions

Intervention1: Intravenous dexmedetomidine infusion: Subject will receive continuous intravenous dexmedetomidine infusion at dose of 0.25 mcg/kg/hr to maximum dose of 0.75 mcg/kg/hr for maximum durati

Sponsors

UCMS and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged between 1 year to 12 year, admitted in PICU and requiring mechanical ventilation

Exclusion criteria

Exclusion criteria: 1. History of known allergy or reaction to dexmedetomidine or midazolam or fentanyl 2. Patients with neuro-paralytic disorder 3. Patients already on sedation 4. Patients with hepatic involvement

Design outcomes

Primary

MeasureTime frame
Percentage of time spent in level -3 to -4 of RASSTimepoint: From enrollment to 48 hours of study

Secondary

MeasureTime frame
Time to achieve -3 or -4 sedation level of RASSTimepoint: From enrollment to time taken to achieve -3 or -4 level of RASS;Number of additional boluses requiredTimepoint: From enrollment to 48 hours of study;Episodes of bradycardia, hypotension and any other adverse effectTimepoint: From enrollment to 48 hours of study

Countries

India

Contacts

Public ContactDr Unnati Sharma

University College of Medical Sciences and GTB hospital, Delhi

drprernabatra@yahoo.com9958672759

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026