Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

• Status: Completed
• Trial end date: 2008-12-30
• Target enrollment: 0
• Participant gender: All

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 been burned.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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