Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Ullevaal University Hospital

Status and phase: Unknown; Phase 3

Conditions: Sedation

Treatments: Drug: dexmedetomidine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01091818

dexmedetmidazchildintsed

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

midazolam

Active Comparator group

Treatment:

Drug: Midazolam

dexmedetomidin

Experimental group

Treatment:

Drug: dexmedetomidine