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Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01091818
First received: March 22, 2010
Last updated: July 20, 2011
Last verified: July 2011

March 22, 2010
July 20, 2011
March 2010
October 2011   (final data collection date for primary outcome measure)
Time from end of sedation to extubation [ Time Frame: 1-24 hrs ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01091818 on ClinicalTrials.gov Archive Site
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Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Sedation
  • Drug: dexmedetomidine
    Dexemedethomidine is given as major sedative drug
    Other Name: Midazolam is given as major sedative drug
  • Drug: Midazolam
    Midazolam is given as major sedative drug
  • Active Comparator: midazolam
    Intervention: Drug: Midazolam
  • Experimental: dexmedetomidin
    Intervention: Drug: dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Norway
 
NCT01091818
dexmedetmidazchildintsed
Not Provided
Johan Rader/Professor, University of Oslo
Ullevaal University Hospital
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Oslo University Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP