Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl +
dexmedetomidine as the initial regimen for maintenance of sedation in
mechanically-ventilated, critically ill children.
This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with
fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be
administered with fentanyl, which will be titrated to achieve sedation scores consistent with
response to light touch. Plasma samples and bedside assessments for pain, sedation, and
delirium will be collected.
Phase:
Phase 1
Details
Lead Sponsor:
Duke University
Collaborators:
Intermountain Health Care, Inc. Johns Hopkins University National Institutes of Health (NIH) Vanderbilt University Medical Center