Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erik S. Shank, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00697788
First received: June 12, 2008
Last updated: December 11, 2011
Last verified: December 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.

Resource links provided by NLM:


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 ]

Enrollment: 9
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexmedetomidine
    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.
    Other Name: Precedex
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

Locations
United States, Massachusetts
Shriners Burn Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Erik S Shank, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Erik S. Shank, MD, Pediatric Anesthesiologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00697788     History of Changes
Other Study ID Numbers: 2005-P-001264/1;MGH
Study First Received: June 12, 2008
Last Updated: December 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
pediatric
burn
sedation

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014