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Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00697788
First Posted: June 16, 2008
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erik S. Shank, MD, Massachusetts General Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 Erik S. Shank, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Percent Change in Mean Arterial Pressure (MAP) [ Time Frame: 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:
  • Presence of Arrhythmias. [ Time Frame: 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 [ Time Frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration ]
    Pulse oximetry was used to measure oxygen saturation.

  • Heart Rate [ Time Frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration ]
    Heart Rate recorded off EKG in beats per minute


Enrollment: 8
Actual Study Start Date: July 16, 2007
Study Completion Date: December 30, 2008
Primary Completion Date: December 30, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ascending dose study
Ascending doses of dexmedetomidine (as per protocol)
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

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 12, 2008
First Posted: June 16, 2008
Results First Submitted: December 6, 2016
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Erik S. Shank, MD, 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
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