Status:
COMPLETED
Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ministry of Food and Drug Safety, Korea
Conditions:
Intensive Care Unit
Postoperative Care
Eligibility:
All Genders
7-18 years
Phase:
PHASE2
Brief Summary
This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for ...
Detailed Description
Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established f...
Eligibility Criteria
Inclusion
- Pediatric patients planned to undergo mechanical ventilation at intensive care unit after surgery
- Pediatric patients planned to be extubated within 4 hours after surgery for neurological examination
- Patients whose parent of legal guardian agreed to enroll in the study after having enough time to review the complete explanation about the study.
Exclusion
- History of hypersensitivity to any drugs including dexmedetomidine.
- Underlying cardiovascular/circulatory disease
- Underlying liver / kidney disease
- Patients under hemodialysis
- Obesity of BMI \> 35
- Patients planned to receive patient-controlled analgesia including opioids
- Patients whose parent or legal guardian declined to enroll in the study
- Other conditions deemed unsuitable for the study
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04027829
Start Date
August 14 2019
End Date
November 14 2019
Last Update
April 14 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Jongro Gu, South Korea, 03080