Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.

Conditions
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Burns, Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascending dose study<br>Ascending doses of dexmedetomidine (as per protocol) | Drug: Dexmedetomidine<br>* Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Mean Arterial Pressure (MAP) | Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure. | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Arrhythmias. | Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study. | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration | 
| Oxygen Saturation | Pulse oximetry was used to measure oxygen saturation. | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration | 
| Heart Rate | Heart Rate recorded off EKG in beats per minute | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, burn, sedation