Polypharmacy-related Adverse Events in Critically Ill Children

Withdrawn before enrolling · Phase 2

Conditions studied: Delirium

In brief

The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.

Key facts

Study ID

NCT03293927

Run by

Duke University

People needed

0

Starts

2018-04-09

Expected to finish

2019-07-01

Last updated by the study team

2019-07-18

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 2-<18 at the time of enrollment
• Admitted to the Duke PICU or PCICU
• Planned or anticipated mechanically ventilation for ≥2 days
• Require sedation to maintain mechanical ventilation
• No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment
• Availability and willingness of the parent/legal guardian to provide written informed consent

You may not qualify if…

• Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
• Previous participation in this study
• Planned receipt of sedatives other than fentanyl or dexmedetomidine
• Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.
• Renal failure requiring renal replacement therapy
• Hepatic failure
• Support with extracorporeal membrane oxygenation

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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