Medication used for sedation in mechanically ventilated childre
- 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.
- Registration Number
- CTRI/2016/05/006925
- Lead Sponsor
- Director JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 430
Children aged <= 12 years admitted in PICU for mechanical ventilation with anticipated to require sedation for >24 hours.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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