Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

Overview

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.

Full Title of Study: “Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 15, 2024

Interventions

  • Drug: Clonidine (without protocolized initiation)
    • Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
  • Drug: Clonidine (protocolized initiation)
    • Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours. Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours. Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours. Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of >/= 168 hours or with infusion time of 120-167 hours at doses >/= 1.1 mcg/kg/min. If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with withdrawal as indicated by score on the Withdrawal Assessment Tool (WAT)
    • Time Frame: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-6 days)
    • A WAT score of >/= 3 will indicate withdrawal. Total WAT score range is 0 to 12, and a higher score indicates more significant withdrawal. WAT scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued, and any participant with a A WAT score of >/= 3 during this time will be considered to have withdrawal.

Secondary Measures

  • Days on dexmedetomidine
    • Time Frame: During time in Pediatric Intensive Care Unit (about 5 to 7 days)
    • number of total days of dexmedetomidine
  • Pediatric Intensive Care Unit (PICU) length of stay
    • Time Frame: During time in Pediatric Intensive Care Unit (about 5 to 7 days)
    • number of days in the PICU
  • Sedation costs
    • Time Frame: During time in Pediatric Intensive Care Unit (about 5 to 7 days)
    • cost during hospitalization for sedation (both enteral and intravenous)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Weeks

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrea Leigh Heifner, Clinical Fellow – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Andrea Heifner, MD, Principal Investigator, The University of Texas Health Science Center, Houston

References

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Nguyen TL, Lam WM, Orr H, Gulbis B, Mauricio R, Tom E, Modem VM, Coronado-Munoz A. Clonidine for the Treatment of Agitation After Dexmedetomidine Discontinuation in Pediatric Patients: A Retrospective Cohort Study. J Pediatr Pharmacol Ther. 2021;26(8):821-827. doi: 10.5863/1551-6776-26.8.821. Epub 2021 Nov 10.

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