Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Phase 3

• Conditions: Sedation
• Interventions: Drug: Midazolam; Drug: dexmedetomidine

• Registration Number: NCT01091818
• Lead Sponsor: Ullevaal University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam	Midazolam	-
dexmedetomidin	dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Time from end of sedation to extubation	1-24 hrs

Trial Locations

Locations (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway