Dexmedetomidine versus Midazolam for sedation in Pediatric Intensive Care Unit

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076689

Enrollment

180

Registered

2024-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: J962- Acute and chronic respiratory failure Health Condition 2: J188- Other pneumonia, unspecified organism Health Condition 3: J969- Respiratory failure, unspecified

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine infusion as primary sedative agent, to be titrated from 0.3 to 1.5 mcg/kg/hour, for a period of 120 hours, or till extubation, or till death

whichever is earlier Control Intervention1: Midazolam: Midazolam infusion as primary sedative agent, to be titrated from 1 to 5 mcg/kg/min, for a period of 120 hours, or till extubation, or till death

whichever is earlier.

Eligibility

Inclusion criteria

Inclusion criteria: Mechanically ventilated children in PICU

Exclusion criteria

Exclusion criteria: Children with raised intracranial pressure, HIE sequelae, refractory shock, bradycardia

Design outcomes

Primary

Measure	Time frame
Efficacy of sedationTimepoint: 5 days	—

Secondary

Measure	Time frame
Delirium, Bolus doses of sedoanalgesia, iatrogenic withdrawal syndrome, adverse effectsTimepoint: 5 days	—

Countries

India

Contacts

Public ContactNarayanan P

Senior Resident, Pediatrics

bismansingh3@gmail.com9643027236

Outcome results

None listed

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