Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
|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.|
|ClinicalTrials.gov Identifier: NCT00697788|
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Burns Sedation||Drug: Dexmedetomidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.|
|Actual Study Start Date :||July 16, 2007|
|Primary Completion Date :||December 30, 2008|
|Study Completion Date :||December 30, 2008|
Experimental: Ascending dose study
Ascending doses of dexmedetomidine (as per protocol)
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
- 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.
- 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
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
|United States, Massachusetts|
|Shriners Burn Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Erik S Shank, MD||Massachusetts General Hospital|