Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sedation
Intervention: dexmedetomidine (Drug); Midazolam (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Ullevaal University Hospital
Summary
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.
Clinical Details
Official title: A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Time from end of sedation to extubation
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- informed consent from parents
- age between 2 and 18 years
- anticipated need of respirator treatment for more than 24 hrs
- included in study within 48 hrs of admission to intensive care unit (ICU)
Exclusion Criteria:
- severe, unstable circulatory failure
- severe intracranial or spinal trauma with circulatory instability
- sever bradycardia or atrioventricular (A-V) block
- liver failure
- less than 50% chance of anticipated survival
- known allergy to study drugs
Locations and Contacts
Dept of Anesthesiology, Oslo University Hospital, Ullevaal, Oslo 0407, Norway; Recruiting Johan Rader, PhD, Phone: 004792249669, Email: johan.rader@medisin.uio.no
Additional Information
Starting date: March 2010
Last updated: July 20, 2011
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