Delirium
Conditions
Keywords
children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy
Brief summary
The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.
Interventions
DRUGFentanyl
The patient will receive IV fentanyl
DRUGDexmedetomidine
The patient will receive IV dexemedetomidine
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in delirium scores as measured by CAPD score | up to 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Drug level associated with CAPD score | up to 10 days |
Countries
United States
Outcome results
None listed