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Efficacy of sedation between drugs dexmedetomidine and midazolam

Comparison of efficacy of dexmedetomidine vs midazolam for sedation in children on mechanical ventilation - NILL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087461
Enrollment
60
Registered
2025-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: I00-I99- Diseases of the circulatory system Health Condition 2: J00-J99- Diseases of the respiratory system Health Condition 3: S00-T88- Injury, poisoning and certain other consequences of external causes

Interventions

Intervention1: Inj Dexmedetomidine: 2 ml of dexmedetomidine (1 ml=100 mcg) will be diluted with 48 ml of 0.9% saline to get a concentration of 4 mcg/ml .Starting with a dose of 0.1 mcg/kg/hr Infusion,

Sponsors

RUSHIKESH RAMESH MUNDE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Children Between 1month to 12 Years of Age on mechanical ventilation admitted in PICU requiring sedation

Exclusion criteria

Exclusion criteria: 1 Children with catecholamine resistant shock 2 Atrioventricular conduction block 3 Hepatic Impairment 4 Infusion of muscle relaxants 5 Parents not willing to participate in study

Design outcomes

Primary

MeasureTime frame
Targeted sedation for primary outcome was between comfort B score 12 to 17Timepoint: Targeted sedation for primary outcome will be monitored every 3 hourly for 48 hours

Secondary

MeasureTime frame
Side effects & number of escalation doses will be compared between two drugsTimepoint: Heart rate saturation blood pressure will be monitored 6 hourly

Countries

India

Contacts

Public ContactRushikesh Ramesh Munde

Government medical college and hospital Chhatrapati sambhajinagar

pmorekhaire@rediffmail.com9850947118

Outcome results

None listed

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