Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Withdrawal; Therapeutic Substance

Treatments: Drug: Clonidine (without protocolized initiation); Drug: Clonidine (protocolized initiation)

Study type: Interventional

Funder types: Other

Identifiers

NCT05575219

HSC-MS-22-0410

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 4 weeks to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Usual care (without protocolized clonidine initiation)

Active Comparator group

Description:

Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.

Treatment:

Drug: Clonidine (without protocolized initiation)

Intervention (protocolized clonidine initiation)

Experimental group

Description:

A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.

Treatment:

Drug: Clonidine (protocolized initiation)