Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Completed · Phase 2

Conditions studied: Burns, Sedation

In brief

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.

Key facts

Study ID

NCT00697788

Run by

Massachusetts General Hospital

People needed

8

Starts

2007-07-16

Expected to finish

2008-12-30

Last updated by the study team

2017-07-17

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shriners Burn Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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