DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sedation

Intervention: dexmedetomidine (Drug); Midazolam (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ullevaal University Hospital

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.

Clinical Details

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

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

Primary outcome: Time from end of sedation to extubation

Eligibility

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Dept of Anesthesiology, Oslo University Hospital, Ullevaal, Oslo 0407, Norway; Recruiting
Johan Rader, PhD, Phone: 004792249669, Email: johan.rader@medisin.uio.no
Additional Information

Starting date: March 2010
Last updated: July 20, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017