Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

NCT00697788 | Completed Phase 2 Results

• 1 other identifier: 2005-P-001264/1;MGH
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Sedation

Keywords

pediatric; burn; sedation

Outcome Measures

Primary Outcomes (1)

• Percent Change in Mean Arterial Pressure (MAP)

  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 Outcomes (3)

• Presence of Arrhythmias.

  10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

• Oxygen Saturation

  10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

• Heart Rate

  10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Study Arms (1)

Ascending dose study

EXPERIMENTAL

Ascending doses of dexmedetomidine (as per protocol)

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

Ascending dose study

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Shriners Burn Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Erik Shank, MD
• Organization: Mass General Hospital for Children

eshank@partners.org

6177242250

Study Officials

• Erik S Shank, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: July 16, 2007
• Primary Completion: December 30, 2008
• Study Completion: December 30, 2008
• Last Updated: July 17, 2017
• Results First Posted: July 17, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)