Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

June 19, 2017 updated by: Erik S. Shank, MD, Massachusetts General Hospital

Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Shriners Burn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
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.
10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
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
10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Erik S Shank, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2007

Primary Completion (Actual)

December 30, 2008

Study Completion (Actual)

December 30, 2008

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (Estimate)

June 16, 2008

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-P-001264/1;MGH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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