Polypharmacy-related Adverse Events in Critically Ill Children

• Status: Withdrawn
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Dexmedetomidine; Fentanyl

Criteria

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