Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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 with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Treatments: Dexmedetomidine

Criteria

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.