Congenital Heart Disease Clinical Trial
Official title:
Dose Escalation Pharmacokinetic Study of Intranasal Atomized Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Verified date | September 2023 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.
Status | Terminated |
Enrollment | 28 |
Est. completion date | October 12, 2021 |
Est. primary completion date | October 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 6 Years |
Eligibility | Inclusion Criteria: 1. Male or female subjects age =1 mo to =6 yo. 2. Subjects must have congenital heart disease. 3. American Society of Anesthesiology (ASA) Physical Status 1-3. 4. Subjects scheduled for elective cardiac interventional or diagnostic catheterization anticipated to last = 3hours. 5. Subjects spontaneously ventilating with a natural airway scheduled for elective cardiac interventional or diagnostic catheterization anticipated to last = 2 hours. 6. Subjects must have reliable intravascular access from which to draw blood samples. Exclusion Criteria: 1. History of allergic reaction or sensitivity to dexmedetomidine. 2. Nasal pathology preventing the administration of drug. 3. Patients that are on maintenance medications that could inhibit or induce the CYP2A6 enzyme. 4. Cardiac conduction abnormalities defined as second or third degree heart block or pacemaker dependence. 5. Bradycardia, defined by age, upon arrival in the preoperative care area. 6. 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. 7. The subject has received dexmedetomidine or clonidine within 1 week of the study date. 8. BMI >30. 9. Patients previously enrolled in this study. 10. Any investigational drug use within 30 days prior to enrollment. 11. Wards will not be eligible. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Samples Obtained Per Subject | Following the administration of atomized intranasal dexmedetomidine, serum samples will be drawn at 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes post drug administration. This is the number of samples obtained per subject. | Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration | |
Primary | Time of Peak Drug Concentration Level of Dexmedetomidine | Following the administration of atomized intranasal dexmedetomidine, serum samples will be drawn at 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes post drug administration. The time of peak drug concentration will be determined based on this data. | Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration | |
Primary | Serum Drug Concentration Levels of Dexmedetomidine | Following administration of atomized intranasal dexmedetomidine, serum samples will be obtained at the following times post administrations: 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes. Peak concentration will be determined based on this data. | Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration | |
Primary | Dose-limiting Toxicities (DLT) and/or Maximum Plasma Level > 1000 pg/mL | Dose-limiting toxicities (DLT) include bradycardia, hypotension, new intraventricular conduction abnormality or any serious adverse event possibly, probably, or definitely related to intranasal dexmedetomidine administration that occured after the administration of the intranasal dexmedetomidine and through the completion of PK sampling. Bradycardia, hypotension, or new intraventricular conduction abnormalities that occured after the administration of intravenous dexmedetomidine given by the primary anesthesia team as part of usual clinical care were not considered DLTs but were considered an adverse event. Any events that could not be explained by the intervention that the patient was undergoing were assumed to be related to the study drug. | Subjects were monitored for 6 hours after the administration of study drug. |
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