Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Burns Clinical Trial

Official title:

Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697788
• Other study ID #: 2005-P-001264/1;MGH
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: December 11, 2011
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Sedation

Intervention

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.

Locations

Country	Name	City	State
United States	Shriners Burn Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs (EKG, BP, O2 Sat, Heart Rate)		immediately, while administering medication.	Yes