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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
Sponsor:
Information provided by:
Oslo University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Sedation Drug: dexmedetomidine Drug: Midazolam Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: midazolam Drug: Midazolam
Midazolam is given as major sedative drug
Experimental: dexmedetomidin Drug: dexmedetomidine
Dexemedethomidine is given as major sedative drug
Other Name: Midazolam is given as major sedative drug



Primary Outcome Measures :
  1. Time from end of sedation to extubation [ Time Frame: 1-24 hrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Norway
Dept of Anesthesiology, Oslo University Hospital, Ullevaal Recruiting
Oslo, Norway, 0407
Contact: Johan Rader, PhD    004792249669    johan.rader@medisin.uio.no   
Sponsors and Collaborators
Ullevaal University Hospital

Responsible Party: Johan Rader/Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01091818     History of Changes
Other Study ID Numbers: dexmedetmidazchildintsed
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Oslo University Hospital:
To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in children
treatment

Additional relevant MeSH terms:
Dexmedetomidine
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents