Polypharmacy-related Adverse Events in Critically Ill Children

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

Official Title
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Investigating Polypharmacy-related Adverse Events in Critically Ill Children

Conditions
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Delirium

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl + Dexmedetomidine<br> | Drug: Fentanyl<br>* The patient will receive IV fentanyl<br>Drug: Dexmedetomidine<br>* The patient will receive IV dexemedetomidine<br>|
| Experimental: Dexmedetomidine + Fentanyl<br> | Drug: Fentanyl<br>* The patient will receive IV fentanyl<br>Drug: Dexmedetomidine<br>* The patient will receive IV dexemedetomidine<br>|
| Experimental: Fentanyl only<br> | Drug: Fentanyl<br>* The patient will receive IV fentanyl<br>|
| Experimental: Dexmedetomidine only<br> | Drug: Dexmedetomidine<br>* The patient will receive IV dexemedetomidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in delirium scores as measured by CAPD score |  | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug level associated with CAPD score |  | up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy