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Comparison of Dexmedetomidine with Midazolam for sedation in mechanically ventilated children in Pediatric intensive care unit.

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
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023636
Enrollment
430
Registered
2020-02-27
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: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine group: will receive 0.2 microgram/kg/hr to 1.2 microgram/kg/hr till extubation Control Intervention1: Midazolam: Midazolam group will receive 0.06 mg/k

Sponsors

AIIMS Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged require sedation for >24 hours.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
length of mechanical ventilation. Timepoint: At extubation

Secondary

MeasureTime frame
Adverse of the study drugsTimepoint: After randomisation;Length of Hospital StayTimepoint: Discharge from hospital;Length of PICU stayTimepoint: Transfer from PICU to Ward;Number of intermittent dose requirements of opioids (Fentanyl and/or morphine) for sedation or analgesia Timepoint: after randomisation

Countries

India

Contacts

Public ContactDR ATUL JINDAL

Department of pediatrics, AIIMS, Raipur, C.G.

dratuljindal@gmail.com08224014667

Outcome results

None listed

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