Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

Phase 4

Completed

• Conditions: Withdrawal; Therapeutic Substance
• Interventions: Drug: Clonidine (without protocolized initiation); Drug: Clonidine (protocolized initiation)

• Registration Number: NCT05575219
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to determine if the protocolized use of clonidine will reduce dexmedetomidine withdrawal symptoms, reduce PICU length of stay, and reduce costs related to sedation during hospital admission.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-07
• Study Start: 2022-10-08
• Study First Posted: 2022-10-12
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2025-01
• Results First Submitted: 2025-01-02
• Results First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Results First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Dexmedetomidine infusion for greater than or equal to 72 hours

Exclusion Criteria

• Admission for head trauma
• Psychiatric history
• Use of alpha-2 agonist medications at home
• Death while on dexmedetomidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care (without protocolized clonidine initiation)	Clonidine (without protocolized initiation)	Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Intervention (protocolized clonidine initiation)	Clonidine (protocolized initiation)	A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Withdrawal	from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)	The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued.; WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal.; The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.

Secondary Outcome Measures

Name	Time	Method
Hours on Dexmedetomidine	During time in Pediatric Intensive Care Unit (about 260 Hours)	number of total hours on dexmedetomidine
Pediatric Intensive Care Unit (PICU) Length of Stay	During time in Pediatric Intensive Care Unit (about 10 to 30 days)	number of days in the PICU
Dexmedetomidine Cost Per Kilogram During Hospitalization	During time in Pediatric Intensive Care Unit (about 24 days)
Clonidine Cost Per Kilogram During Hospitalization	During time in Pediatric Intensive Care Unit (about 24 days)

Trial Locations

Locations (1)

Children's Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States