Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

NCT ID: NCT01091818

Last Updated: 2011-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam is given as major sedative drug

dexmedetomidin

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

Dexemedethomidine is given as major sedative drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dexmedetomidine

Dexemedethomidine is given as major sedative drug

Intervention Type DRUG

Midazolam

Midazolam is given as major sedative drug

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Midazolam is given as major sedative drug

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Oslo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Johan Rader, PhD

Role: primary

004792249669

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

dexmedetmidazchildintsed

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.