Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

Study Overview
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Brief Summary
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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.

Official Title
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Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study

Conditions
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Withdrawal; Therapeutic Substance

Intervention / Treatment
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* Drug: Clonidine (without protocolized initiation)
* Drug: Clonidine (protocolized initiation)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care (without protocolized clonidine initiation)<br>Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion. | Drug: Clonidine (without protocolized initiation)<br>* Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.<br>* Other names: Clondine;|
| Experimental: Intervention (protocolized clonidine initiation)<br>A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine. | Drug: Clonidine (protocolized initiation)<br>* 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 120-167 hours. Decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 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. Decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).<br>* Other names: Clondine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with withdrawal as indicated by score on the Withdrawal Assessment Tool (WAT) | 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. | from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-6 days) | 

Secondary Outcome Measures

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