Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

• Status: Unknown status
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ullevaal University Hospital
• Treatments: Dexmedetomidine; Hypnotics and Sedatives; Midazolam

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