Duke logo

Medication-Related Adverse Events in Critically Ill Children - Clinical Trial

What is the Purpose of this Study?

We are doing this study is to learn how 2 medicines, Fentanyl and Dexmedetomidine, affect how sick children think and interact with their environments.

What is the Condition Being Studied?

Pain medicine use for children in the intensive care unit

Who Can Participate in the Study?

Children who: 
- Are ages 2 to 17 years old. 
- Are admitted to the hospital ICU (PICU or PCICU).
- Have a planned or have a mechanical ventilation for 2 or more days.
- Require sedation to maintain ventilation.

Age Group
Children

What is Involved?

If you decide that you would like for your child to be part of this study, your child will:
- Be involved in the study for 10 days
- Be randomly assigned (like the flip of a coin) to get either dexmedetomidine or fentanyl
- Be observed for signs of confusion twice a day
- Give up to 10 blood samples

Study Details

Full Title
Investigating polypharmacy-related adverse events in critically ill children
Principal Investigator
Kanecia Zimmerman
Protocol Number
IRB:PRO00084476
NCT:NCT03293927
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698