Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Sedation Clinical Trial

Official title:

A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01091818
• Other study ID #: dexmedetmidazchildintsed
• Status: Recruiting
• Phase: Phase 3
• First received: March 22, 2010
• Last updated: July 20, 2011
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2011
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• dexmedetomidine
Dexemedethomidine is given as major sedative drug
• Midazolam
Midazolam is given as major sedative drug

Locations

Country	Name	City	State
Norway	Dept of Anesthesiology, Oslo University Hospital, Ullevaal	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from end of sedation to extubation		1-24 hrs	Yes