Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Phase 2

Completed

• Conditions: Burns; Sedation
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT00697788
• Lead Sponsor: Massachusetts General Hospital

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 been burned.

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

Study Timeline

• Study Start: 2007-07-16
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-16
• Primary Completion: 2008-12-30
• Study Completion: 2008-12-30
• Results First Submitted: 2016-12-06
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Results First Posted: 2017-07-17
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ascending dose study	Dexmedetomidine	Ascending doses of dexmedetomidine (as per protocol)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shriners Burn Hospital; 🇺🇸 Boston, Massachusetts, United States