Trial · NCT05575219
Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal
NCT05575219, Phase 4, Completed, The University of Texas Health Science Center, Houston; results first posted 2025-01-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal. Trials, record NCT05575219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05575219
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal
- NCT number
- NCT05575219
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 128 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Withdrawal; Therapeutic Substance
- Interventions
- Clonidine (without protocolized initiation), Clonidine (protocolized initiation)
- First posted
- 2022-10-12
- Last updated
- 2025-01-28
- Results first posted
- 2025-01-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Hours on Dexmedetomidine | During time in Pediatric Intensive Care Unit (about 260 Hours) | number of total hours on dexmedetomidine |
| Secondary | 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 |
| Secondary | Dexmedetomidine Cost Per Kilogram During Hospitalization | During time in Pediatric Intensive Care Unit (about 24 days) | |
| Secondary | Clonidine Cost Per Kilogram During Hospitalization | During time in Pediatric Intensive Care Unit (about 24 days) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Withdrawal | from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hours on Dexmedetomidine | During time in Pediatric Intensive Care Unit (about 260 Hours) | Hours | MEDIAN | |
| SECONDARY | Pediatric Intensive Care Unit (PICU) Length of Stay | During time in Pediatric Intensive Care Unit (about 10 to 30 days) | Data were not collected for 8 participants in the Usual care (without protocolized clonidine initiation) arm. | Days | MEDIAN |
| SECONDARY | Dexmedetomidine Cost Per Kilogram During Hospitalization | During time in Pediatric Intensive Care Unit (about 24 days) | dollars per kilogram | MEDIAN | |
| SECONDARY | Clonidine Cost Per Kilogram During Hospitalization | During time in Pediatric Intensive Care Unit (about 24 days) | cents per kilogram | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Withdrawal | Usual Care (Without Protocolized Clonidine Initiation) | 33 | Participants | ||
| Number of Participants With Withdrawal | Intervention (Protocolized Clonidine Initiation) | 10 | Participants | ||
| Hours on Dexmedetomidine | Usual Care (Without Protocolized Clonidine Initiation) | 153.43 | Inter-Quartile Range 114.79 to 218.62 | Hours | |
| Hours on Dexmedetomidine | Intervention (Protocolized Clonidine Initiation) | 155.33 | Inter-Quartile Range 132.83 to 260.23 | Hours | |
| Pediatric Intensive Care Unit (PICU) Length of Stay | Usual Care (Without Protocolized Clonidine Initiation) | 13 | Inter-Quartile Range 9 to 28 | Days | |
| Pediatric Intensive Care Unit (PICU) Length of Stay | Intervention (Protocolized Clonidine Initiation) | 10.5 | Inter-Quartile Range 8.75 to 16.25 | Days | |
| Dexmedetomidine Cost Per Kilogram During Hospitalization | Usual Care (Without Protocolized Clonidine Initiation) | 19.98 | Inter-Quartile Range 14.5 to 32.72 | dollars per kilogram | |
| Dexmedetomidine Cost Per Kilogram During Hospitalization | Intervention (Protocolized Clonidine Initiation) | 29.46 | Inter-Quartile Range 20.19 to 47.64 | dollars per kilogram | |
| Clonidine Cost Per Kilogram During Hospitalization | Usual Care (Without Protocolized Clonidine Initiation) | 0.06 | Inter-Quartile Range 0.03 to 0.14 | cents per kilogram | |
| Clonidine Cost Per Kilogram During Hospitalization | Intervention (Protocolized Clonidine Initiation) | 0.05 | Inter-Quartile Range 0.02 to 0.1 | cents per kilogram |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care (Without Protocolized Clonidine Initiation) | 96 | |
| Overall Study | STARTED | Intervention (Protocolized Clonidine Initiation) | 32 | |
| Overall Study | COMPLETED | Usual Care (Without Protocolized Clonidine Initiation) | 96 | |
| Overall Study | COMPLETED | Intervention (Protocolized Clonidine Initiation) | 32 | |
| Overall Study | NOT COMPLETED | Usual Care (Without Protocolized Clonidine Initiation) | 0 | |
| Overall Study | NOT COMPLETED | Intervention (Protocolized Clonidine Initiation) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care (Without Protocolized Clonidine Initiation) | 0 | 96 |
| Total, all-cause mortality | Intervention (Protocolized Clonidine Initiation) | 0 | 32 |
| Total, other adverse events | Usual Care (Without Protocolized Clonidine Initiation) | 0 | 96 |
| Total, other adverse events | Intervention (Protocolized Clonidine Initiation) | 0 | 32 |
| Total, serious adverse events | Usual Care (Without Protocolized Clonidine Initiation) | 0 | 96 |
| Total, serious adverse events | Intervention (Protocolized Clonidine Initiation) | 0 | 32 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention (Protocolized Clonidine Initiation) vs Usual Care (Without Protocolized Clonidine Initiation): Number of Participants With Withdrawal | Trial comparisons |
| Intervention (Protocolized Clonidine Initiation) vs Usual Care (Without Protocolized Clonidine Initiation): deaths from any cause | Trial comparisons |
| Intervention (Protocolized Clonidine Initiation) vs Usual Care (Without Protocolized Clonidine Initiation): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05575219
GET https://conductscience.org/api/trials/v1/NCT05575219/registered