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Comparing Dexmedetomidine Versus Midazolam for Sedation in Children Receiving Mechanical Ventilation

A Randomised controlled trial to compare safety and efficacy of dexmedetomidine versus midazolam continuous infusion for sedation in mechanically ventilated children - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100359
Enrollment
60
Registered
2026-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: J181- Lobar pneumonia, unspecified organism

Interventions

Intervention1: Dexmedetomidine infusion: Midazolam bolus 0.1mg/kg will be given to both groups, dexmedetomidine infusion dose 0.25mcg/kg/hour and titrated in increments of 0.25mcg/kg/hour upto maximum

Sponsors

Pt. Bhagwat Dayal Sharma post graduate institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 month to 14 years on invasive mechanical ventilation in paediatric ICU

Exclusion criteria

Exclusion criteria: 1.Children with catecholamine-resistant shock. 2. Children already receiving continuous sedative infusion prior to PICU admission. 3. Children with baseline bradycardia. 4. Children with known atrioventricular conduction abnormalities or heart block.

Design outcomes

Primary

MeasureTime frame
The percentage of time spent in target sedation range as PSCH sedation algorithm for mechanically ventilated children.Timepoint: To be assessed after seven days

Secondary

MeasureTime frame
1.Duration of mechanical ventilation (onset of ventilation to successful extubation) 2.Length of PICU stay 3.Incidence of adverse effects Bradycardia, Hypotension, Respiratory depressionTimepoint: To be assessed for seven days

Countries

India

Contacts

Public ContactDrPallavi Parihar

Pt. Bhagwat Dayal Sharma post graduate institute of medical sciences , Rohtak

Pallaviparihar77@gmail.com7067119954

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026