Status:
COMPLETED
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Burns
Sedation
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief Summary
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently b...
Detailed Description
This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by ...
Eligibility Criteria
Inclusion
- pediatric patient
- \>25% total body surface area (tbsa) burn and \< 90% tbsa
- opioid requirements \> 0.1 mg/kg/hour of morphine (or equivalent)
- midazolam requirement \> 0.1 mg/kg/hour
- treatment team determined that patient should be started on dexmedetomidine
Exclusion
- hemodynamically unstable patients (epinephrine \> 1.0 ug/kg/min, levophed \> 0.75 ug/kg/min, dopamine \> 10 ug/kg/min)
- pregnant patients
- patients with history of heart block
- patients with congenital heart disease
- patients with significant hepatic dysfunction
- patients with urine output \< 0.5 ml/kg/hour \[averaged\] over past 24 hours
Key Trial Info
Start Date :
July 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00697788
Start Date
July 16 2007
End Date
December 30 2008
Last Update
July 17 2017
Active Locations (1)
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1
Shriners Burn Hospital
Boston, Massachusetts, United States, 02114