Phase 4
N=128
Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal
Withdrawal; Therapeutic Substance
Bottom Line
View on ClinicalTrials.gov: NCT05575219 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Withdrawal — 33; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clonidine (without protocolized initiation) (Drug); Clonidine (protocolized initiation) (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Withdrawal |
33; 10 | — |
| SECONDARY Hours on Dexmedetomidine |
153.43; 155.33 | — |
| SECONDARY Pediatric Intensive Care Unit (PICU) Length of Stay |
13; 10.5 | — |
| SECONDARY Dexmedetomidine Cost Per Kilogram During Hospitalization |
19.98; 29.46 | — |
| SECONDARY Clonidine Cost Per Kilogram During Hospitalization |
0.06; 0.05 | — |
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
Data sourced from ClinicalTrials.gov (NCT05575219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.