Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Sedation; Burns

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00697788

2005-P-001264/1 MGH;

Details and patient eligibility

About

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.

Full 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 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.

Enrollment: 8 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Ascending dose study

Experimental group

Description:

Ascending doses of dexmedetomidine (as per protocol)

Treatment:

Drug: Dexmedetomidine