Polypharmacy-related Adverse Events in Critically Ill Children

Duke University

Status and phase: Withdrawn; Phase 2

Conditions: Delirium

Treatments: Drug: Fentanyl; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03293927

Pro00084476

Details and patient eligibility

About

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

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Fentanyl + Dexmedetomidine

Experimental group

Treatment:

Drug: Dexmedetomidine

Drug: Fentanyl

Dexmedetomidine + Fentanyl

Experimental group

Treatment:

Drug: Dexmedetomidine

Drug: Fentanyl

Fentanyl only

Experimental group

Treatment:

Drug: Fentanyl

Dexmedetomidine only

Experimental group

Treatment:

Drug: Dexmedetomidine