NCT00697788

Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Burns
• Sedation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-07-16
• Primary completion: 2008-12-30
• Completion: 2008-12-30
• First posted: 2008-06-16
• Last updated: 2017-07-17
• Results posted: 2017-07-17

Locations

1 site across 1 country: United States