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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01091818
Enrollment
40
Registered
2010-03-24
Start date
2010-03-31
Completion date
2011-10-31
Last updated
2011-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

Keywords

To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in children, treatment

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.

Interventions

DRUGdexmedetomidine

Dexemedethomidine is given as major sedative drug

DRUGMidazolam

Midazolam is given as major sedative drug

Sponsors

Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time from end of sedation to extubation1-24 hrs

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026