Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

July 20, 2011 updated by: Ullevaal University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Recruiting
        • Dept of Anesthesiology, Oslo University Hospital, Ullevaal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Midazolam is given as major sedative drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from end of sedation to extubation
Time Frame: 1-24 hrs
1-24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dexmedetmidazchildintsed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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