Clinical trial NCT05575219: Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal
Official title: Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Withdrawal; Therapeutic Substance
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 128
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Withdrawal
timeFrame: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)
Secondary outcomes:
measure: Hours on Dexmedetomidine
timeFrame: During time in Pediatric Intensive Care Unit (about 260 Hours)
measure: Pediatric Intensive Care Unit (PICU) Length of Stay
timeFrame: During time in Pediatric Intensive Care Unit (about 10 to 30 days)
measure: Dexmedetomidine Cost Per Kilogram During Hospitalization
timeFrame: During time in Pediatric Intensive Care Unit (about 24 days)
measure: Clonidine Cost Per Kilogram During Hospitalization
timeFrame: During time in Pediatric Intensive Care Unit (about 24 days)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Andrea Heifner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Berrens ZJ, Sauro AL, Tillman EM. Prevention of Withdrawal in Pediatric Patients Receiving Long-term Dexmedetomidine Infusions. J Pediatr Pharmacol Ther. 2021;26(1):81-86. doi: 10.5863/1551-6776-26.1.81. Epub 2021 Jan 4.
citation: Bhatt K, Thompson Quan A, Baumgartner L, Jia S, Croci R, Puntillo K, Ramsay J, Bouajram RH. Effects of a Clonidine Taper on Dexmedetomidine Use and Withdrawal in Adult Critically Ill Patients-A Pilot Study. Crit Care Explor. 2020 Nov 3;2(11):e0245. doi: 10.1097/CCE.0000000000000245. eCollection 2020 Nov.
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citation: Lardieri AB, Fusco NM, Simone S, Walker LK, Morgan JA, Parbuoni KA. Effects of Clonidine on Withdrawal From Long-term Dexmedetomidine in the Pediatric Patient. J Pediatr Pharmacol Ther. 2015 Jan-Feb;20(1):45-53. doi: 10.5863/1551-6776-20.1.45.
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citation: Lee MM, Caylor K, Gockenbach N. Evaluating the Transition From Dexmedetomidine to Clonidine for the Prevention of Withdrawal in Critically Ill Pediatric Patients. J Pediatr Pharmacol Ther. 2020;25(2):104-110. doi: 10.5863/1551-6776-25.2.104.
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