Back to resultsPharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Primary Purpose
Dexmedetomidine, Congenital Heart Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional other trial for Dexmedetomidine focused on measuring Intranasal, Pharmacokinetic, Pediatric
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Cohort 1A: Dexmedetomidine 2 μg/kg Under general oral endotracheal anesthesia 7 subjects age >2 yo and ≤ 6 yo 7 subjects age ≥1 mo and ≤2 yo Cohort 1B: Dexmedetomidine 2 μg/kg Under sedation with a natural airway 7 subjects age >2 yo and ≤ 6 yo 7 subjects age ≥1 mo and ≤2 yo
Dexmedetomidine 4 μg/kg Under general oral endotracheal anesthesia 7 subjects age >2 yo and ≤ 6 yo
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03417999
First Posted
January 8, 2018
Last Updated
December 28, 2021
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT03417999
Brief Title
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Official Title
Dose Escalation Pharmacokinetic Study of Intranasal Atomized Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.
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 facilitate separation from parents and the induction of anesthesia, children are often given a sedative prior to undergoing a procedure. Dexmedetomidine is a highly selective a2-adrenergic receptor agonist with sedative, anxiolytic, and analgesic properties. While off-label in its use, the administration of dexmedetomidine by the intranasal route has become a popular and effective technique for sedation in children because it is non-invasive, easy to administer, well tolerated, and relatively fast in onset. Despite this, little consistent data have been published on its onset time, duration of action, or optimal dose. The only available pharmacokinetic (PK) data on dexmedetomidine in pediatric patients is in children who were administered IV dexmedetomidine. We are proposing a prospective open-label inter-subject cohort dose-escalation pharmacokinetic study to obtain peak dexmedetomidine drug concentration level in plasma and the corresponding time point following intranasal administration in the pediatric patient with cardiac disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Congenital Heart Disease
Keywords
Intranasal, Pharmacokinetic, Pediatric
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Cohort 1A:
Dexmedetomidine 2 μg/kg
Under general oral endotracheal anesthesia
7 subjects age >2 yo and ≤ 6 yo
7 subjects age ≥1 mo and ≤2 yo
Cohort 1B:
Dexmedetomidine 2 μg/kg
Under sedation with a natural airway
7 subjects age >2 yo and ≤ 6 yo
7 subjects age ≥1 mo and ≤2 yo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Dexmedetomidine 4 μg/kg
Under general oral endotracheal anesthesia
7 subjects age >2 yo and ≤ 6 yo
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dose-escalation of atomized intranasal dexmedetomidine
Primary Outcome Measure Information:
Title
Serum drug concentration levels of dexmedetomidine
Description
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.
Time Frame
Up to 5 hours
Title
Time of peak drug concentration level of dexmedetomidine
Description
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.
Time Frame
Up to 5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly L Grogan, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
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