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Clinical Trials/CTRI/2020/02/023636
CTRI/2020/02/023636
Not yet recruiting
Phase 4

Dexmedetomidine versus Midazolam for sedation in mechanically ventilated children in Pediatric intensive care unit: A randomized double blind controlled trial.

AIIMS Raipur0 sites0 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
AIIMS Raipur
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
AIIMS Raipur

Eligibility Criteria

Inclusion Criteria

  • Children aged \< 12 years admitted in PICU for mechanical ventilation with anticipation to
  • require sedation for \>24 hours.

Exclusion Criteria

  • Children with unstable hemodynamics at the time of enrollment (Mean arterial blood pressure \< 5th percentile for age, sex, length/height with \>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 \< 30%) and bradycardia (HR \<60/min)
  • 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.

Outcomes

Primary Outcomes

Not specified

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