Polypharmacy-related Adverse Events in Critically Ill Children

Phase 2

Withdrawn

• Conditions: Delirium
• Interventions: Drug: Dexmedetomidine; Drug: Fentanyl

• Registration Number: NCT03293927
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-26
• Study Start: 2018-04-09
• Status Verified: 2018-10
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine only	Dexmedetomidine	-
Fentanyl + Dexmedetomidine	Dexmedetomidine	-
Fentanyl + Dexmedetomidine	Fentanyl	-
Fentanyl only	Fentanyl	-
Dexmedetomidine + Fentanyl	Fentanyl	-
Dexmedetomidine + Fentanyl	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Change in delirium scores as measured by CAPD score	up to 10 days

Secondary Outcome Measures

Name	Time	Method
Drug level associated with CAPD score	up to 10 days

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States