Withdrawal; Therapeutic Substance
Conditions
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.
Interventions
DRUGClonidine (without protocolized initiation)
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
DRUGClonidine (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).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Withdrawal | from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hours on Dexmedetomidine | During time in Pediatric Intensive Care Unit (about 260 Hours) | number of total hours on dexmedetomidine |
| Pediatric Intensive Care Unit (PICU) Length of Stay | During time in Pediatric Intensive Care Unit (about 10 to 30 days) | number of days in the PICU |
| Dexmedetomidine Cost Per Kilogram During Hospitalization | During time in Pediatric Intensive Care Unit (about 24 days) | — |
| Clonidine Cost Per Kilogram During Hospitalization | During time in Pediatric Intensive Care Unit (about 24 days) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (Without Protocolized Clonidine Initiation) Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion. | 96 |
| Intervention (Protocolized Clonidine Initiation) A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
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). | 32 |
| Total | 128 |
Baseline characteristics
| Characteristic | Usual Care (Without Protocolized Clonidine Initiation) | Intervention (Protocolized Clonidine Initiation) | Total |
|---|---|---|---|
| Age, Continuous | 10 months | 16.5 months | 10.5 months |
| Primary Diagnosis Cardiac Diagnosis | 40 Participants | 0 Participants | 40 Participants |
| Primary Diagnosis Hematology/Oncology Diagnosis | 2 Participants | 2 Participants | 4 Participants |
| Primary Diagnosis Neurologic Diagnosis | 3 Participants | 2 Participants | 5 Participants |
| Primary Diagnosis Other Diagnosis | 2 Participants | 4 Participants | 6 Participants |
| Primary Diagnosis Respiratory Diagnosis | 45 Participants | 22 Participants | 67 Participants |
| Primary Diagnosis Sepsis Diagnosis | 4 Participants | 2 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 96 participants | 32 participants | 128 participants |
| Sex: Female, Male Female | 54 Participants | 21 Participants | 75 Participants |
| Sex: Female, Male Male | 42 Participants | 11 Participants | 53 Participants |
| Weight | 7.515 kilograms | 10.95 kilograms | 8.418 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 32 |
| other Total, other adverse events | 0 / 96 | 0 / 32 |
| serious Total, serious adverse events | 0 / 96 | 0 / 32 |
Outcome results
Primary
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)
Population: Data were not collected from 5 participants in the Usual care (without protocolized clonidine initiation) arm. Data were not collected from 2 participants in the Intervention (protocolized clonidine initiation) arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (Without Protocolized Clonidine Initiation) | Number of Participants With Withdrawal | 33 Participants |
| Intervention (Protocolized Clonidine Initiation) | Number of Participants With Withdrawal | 10 Participants |
Secondary
Clonidine Cost Per Kilogram During Hospitalization
Time frame: During time in Pediatric Intensive Care Unit (about 24 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care (Without Protocolized Clonidine Initiation) | Clonidine Cost Per Kilogram During Hospitalization | 0.06 cents per kilogram |
| Intervention (Protocolized Clonidine Initiation) | Clonidine Cost Per Kilogram During Hospitalization | 0.05 cents per kilogram |
Secondary
Dexmedetomidine Cost Per Kilogram During Hospitalization
Time frame: During time in Pediatric Intensive Care Unit (about 24 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care (Without Protocolized Clonidine Initiation) | Dexmedetomidine Cost Per Kilogram During Hospitalization | 19.98 dollars per kilogram |
| Intervention (Protocolized Clonidine Initiation) | Dexmedetomidine Cost Per Kilogram During Hospitalization | 29.46 dollars per kilogram |
Secondary
Hours on Dexmedetomidine
number of total hours on dexmedetomidine
Time frame: During time in Pediatric Intensive Care Unit (about 260 Hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care (Without Protocolized Clonidine Initiation) | Hours on Dexmedetomidine | 153.43 Hours |
| Intervention (Protocolized Clonidine Initiation) | Hours on Dexmedetomidine | 155.33 Hours |
Secondary
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)
Population: Data were not collected for 8 participants in the Usual care (without protocolized clonidine initiation) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care (Without Protocolized Clonidine Initiation) | Pediatric Intensive Care Unit (PICU) Length of Stay | 13 Days |
| Intervention (Protocolized Clonidine Initiation) | Pediatric Intensive Care Unit (PICU) Length of Stay | 10.5 Days |