NCT05575219

Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 4 Weeks – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Withdrawal; Therapeutic Substance

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-10-08
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2022-10-12
• Last updated: 2025-01-28
• Results posted: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study