Polypharmacy-related Adverse Events in Critically Ill Children
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 10/27/2018 |
| Start Date: | April 9, 2018 |
| End Date: | July 1, 2019 |
| Contact: | Kanecia Zimmerman, MD |
| Email: | kanecia.obie@duke.edu |
| Phone: | 919-668-8651 |
Investigating Polypharmacy-related Adverse Events in Critically Ill Children
The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect
how sick children think and interact with their environments.
how sick children think and interact with their environments.
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
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