Status:
TERMINATED
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Dexmedetomidine
Congenital Heart Disease
Eligibility:
All Genders
1-6 years
Phase:
PHASE1
Brief Summary
The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr wi...
Detailed Description
The high anxiety levels that children may experience during the preoperative period may be associated with negative medical, psychological, and social consequences. To reduce this stress, and to facil...
Eligibility Criteria
Inclusion
- Male or female subjects age ≥1 mo to ≤6 yo.
- Subjects must have congenital heart disease.
- American Society of Anesthesiology (ASA) Physical Status 1-3.
- Subjects scheduled for elective cardiac interventional or diagnostic catheterization anticipated to last ≥ 3hours.
- Subjects spontaneously ventilating with a natural airway scheduled for elective cardiac interventional or diagnostic catheterization anticipated to last ≥ 2 hours.
- Subjects must have reliable intravascular access from which to draw blood samples.
Exclusion
- History of allergic reaction or sensitivity to dexmedetomidine.
- Nasal pathology preventing the administration of drug.
- Patients that are on maintenance medications that could inhibit or induce the CYP2A6 enzyme.
- Cardiac conduction abnormalities defined as second or third degree heart block or pacemaker dependence.
- Bradycardia, defined by age, upon arrival in the preoperative care area.
- Hepatic dysfunction defined as a history of hepatic dysfunction AND an Alanine Aminotransferase (ALT) value greater than 2 times normal in the 6 months prior to study drug administration.
- The subject has received dexmedetomidine or clonidine within 1 week of the study date.
- BMI \>30.
- Patients previously enrolled in this study.
- Any investigational drug use within 30 days prior to enrollment.
- Wards will not be eligible.
Key Trial Info
Start Date :
June 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03417999
Start Date
June 14 2018
End Date
October 12 2021
Last Update
March 22 2024
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19106