Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
|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: NCT01091818|
Recruitment Status : Unknown
Verified July 2011 by Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : March 24, 2010
Last Update Posted : July 21, 2011
Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years.
The investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation.
|Condition or disease||Intervention/treatment||Phase|
|Sedation||Drug: dexmedetomidine Drug: Midazolam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2011|
|Active Comparator: midazolam||
Midazolam is given as major sedative drug
Dexemedethomidine is given as major sedative drug
Other Name: Midazolam is given as major sedative drug
- Time from end of sedation to extubation [ Time Frame: 1-24 hrs ]
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): NCT01091818
|Dept of Anesthesiology, Oslo University Hospital, Ullevaal||Recruiting|
|Oslo, Norway, 0407|
|Contact: Johan Rader, PhD 004792249669 email@example.com|