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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
128
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
* 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).
Children's Memorial Hermann Hospital
Houston, Texas, United States
Number of Participants With Withdrawal
The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued. WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal. The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.
Time frame: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)
Hours on Dexmedetomidine
number of total hours on dexmedetomidine
Time frame: During time in Pediatric Intensive Care Unit (about 260 Hours)
Pediatric Intensive Care Unit (PICU) Length of Stay
number of days in the PICU
Time frame: During time in Pediatric Intensive Care Unit (about 10 to 30 days)
Dexmedetomidine Cost Per Kilogram During Hospitalization
Time frame: During time in Pediatric Intensive Care Unit (about 24 days)
Clonidine Cost Per Kilogram During Hospitalization
Time frame: During time in Pediatric Intensive Care Unit (about 24 days)
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