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
  Purpose

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 Intervention Phase
Sedation
Drug: dexmedetomidine
Drug: Midazolam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Time from end of sedation to extubation [ Time Frame: 1-24 hrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Johan Rader/Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01091818     History of Changes
Other Study ID Numbers: dexmedetmidazchildintsed
Study First Received: March 22, 2010
Last Updated: July 20, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on August 21, 2014