Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00697788

Purpose

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.

Condition	Intervention	Phase
Burns Sedation	Drug: Dexmedetomidine	Phase II

MedlinePlus related topics: Burns

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Vital signs (EKG, BP, O2 Sat, Heart Rate) [ Time Frame: immediately, while administering medication. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697788

Contacts

Contact: Erik S Shank, MD	617-724-3154	eshank@partners.org
Contact: Jeevendra A Matyn, MD	617-371-4766	jmartyn@partners.org

Locations

United States, Massachusetts
Shriners Burn Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Erik S Shank, MD 617-724-3154 eshank@partners.org
Sub-Investigator: Jeevendra A Martyn, MD
Sub-Investigator: Robert L Sheridan, MD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Erik S Shank, MD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Erik S. Shank, MD )
Study ID Numbers:	2005-P-001264/1;MGH
Study First Received:	June 12, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00697788
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

pediatric
burn
sedation

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin
Dexmedetomidine

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Adrenergic Agonists

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009