Polypharmacy-related Adverse Events in Critically Ill Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2019-07-01

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.

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Detailed Description

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Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fentanyl + Dexmedetomidine

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

The patient will receive IV fentanyl

Dexmedetomidine

Intervention Type DRUG

The patient will receive IV dexemedetomidine

Dexmedetomidine + Fentanyl

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

The patient will receive IV fentanyl

Dexmedetomidine

Intervention Type DRUG

The patient will receive IV dexemedetomidine

Fentanyl only

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

The patient will receive IV fentanyl

Dexmedetomidine only

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

The patient will receive IV dexemedetomidine

Interventions

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Fentanyl

The patient will receive IV fentanyl

Intervention Type DRUG

Dexmedetomidine

The patient will receive IV dexemedetomidine

Intervention Type DRUG

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No