Polypharmacy-related Adverse Events in Critically Ill Children

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.

Study Overview

• Status: Withdrawn
• Conditions: Delirium
• Intervention / Treatment: Drug: Fentanyl; Drug: Dexmedetomidine

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl + Dexmedetomidine	Drug: Fentanyl; The patient will receive IV fentanyl; Drug: Dexmedetomidine; The patient will receive IV dexemedetomidine
Experimental: Dexmedetomidine + Fentanyl	Drug: Fentanyl; The patient will receive IV fentanyl; Drug: Dexmedetomidine; The patient will receive IV dexemedetomidine
Experimental: Fentanyl only	Drug: Fentanyl; The patient will receive IV fentanyl
Experimental: Dexmedetomidine only	Drug: Dexmedetomidine; The patient will receive IV dexemedetomidine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kanecia Zimmerman, MD, Duke

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: Pro00084476

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No