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Medication used for sedation in mechanically ventilated children

Dexmedetomidine versus midazolam for sedation in mechanically ventilated children in pediatric intensive care unit: A randomized double blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006925
Enrollment
430
Registered
2016-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Children aged â?¤ 12 years admitted in PICU for mechanical ventilation with anticipated to require sedation for more than 24 hours.

Interventions

Intervention1: Dexmedetomidine: Starting dose of dexmedetomidine will be 0.2 microgram/kg/hour without loading dose. Trial drug will be hiked up in range of 0.05 to 0.1 (0.25 to 0.5ml/hr) microgram/kg

Sponsors

Director JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 24 hours.

Exclusion criteria

Exclusion criteria: 1. Children with unstable hemodynamics at the time of enrollment (Mean arterial blood pressure =2 vasoactive therapy support and/or requiring on going resuscitation) 2. Children requiring mechanical ventilation for neuromuscular diseases 3. Children with severe central nervous system pathology like raised intracranial pressure irrespective of causes, acute cerebrovascular accident, status epilepticus etc. 4. Children with developmental delay 5. Children with evidence of myocardial dysfunction (ejection fraction 6. Requiring dialysis irrespective of type at the time of enrollment. 7. Received general anesthesia 24 hours prior to or planned after the start of study drug infusion. 8. Children with severe liver pathology like acute liver failure, hepatic encephalopathy, chronic liver diases etc. 9. Children with trauma and burns as an admitting diagnosis. 10. Children requiring neuromuscular blockade infusion other than for intubation.

Design outcomes

Secondary

MeasureTime frame
Adverse effects of the study drugs.Timepoint: at end of infusion.;Length of PICU and hospital stayTimepoint: at the discharge from PICU and hospital.;Number of intermittent dose requirements of opioids (Fentanyl and/or morphine) for sedation/analgesiaTimepoint: at the time of extubation and or out from mechanical ventilation

Primary

MeasureTime frame
To compare the length of mechanical ventilation children in those receiving dexmedetomidine as compared to those receiving midazolam.Timepoint: At the time of Extubation and or out of mechanical ventilation.

Countries

India

Contacts

Public ContactDR R RAMESH KUMAR

ASSISTANT PROFESSOR

krramesh_iway@yahoo.co.in7373739142

Outcome results

None listed

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