CTRI/2016/05/006925
Not yet recruiting
未知
Dexmedetomidine versus midazolam for sedation in mechanically ventilated children in pediatric intensive care unit: A randomized double blind controlled trial
Director JIPMER0 sites430 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- 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.
- Sponsor
- Director JIPMER
- Enrollment
- 430
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children aged \<\= 12 years admitted in PICU for mechanical ventilation with anticipated to require sedation for \>24 hours.
Exclusion Criteria
- •1\. 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)
- •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 \< 30%) and bradycardia (heart rate \<60/min)
- •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.
Outcomes
Primary Outcomes
Not specified
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