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

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ClinicalTrials.gov Identifier: NCT03417999
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Kelly Grogan, Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Dexmedetomidine Congenital Heart Disease Drug: Dexmedetomidine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dose Escalation Pharmacokinetic Study of Intranasal Atomized Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Cohort 1

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
Drug: Dexmedetomidine
Dose-escalation of atomized intranasal dexmedetomidine
Other Name: Precedex

Experimental: Cohort 2
  • Dexmedetomidine 4 μg/kg
  • Under general oral endotracheal anesthesia
  • 7 subjects age >2 yo and ≤ 6 yo
  • 7 subjects age ≥1 mo and ≤2 yo
Drug: Dexmedetomidine
Dose-escalation of atomized intranasal dexmedetomidine
Other Name: Precedex

Experimental: Cohort 3
  • Dexmedetomidine 6 μg/kg
  • Under general oral endotracheal anesthesia
  • 7 subjects age >2 yo and ≤ 6 yo
  • 7 subjects age ≥1 mo and ≤2 yo
Drug: Dexmedetomidine
Dose-escalation of atomized intranasal dexmedetomidine
Other Name: Precedex




Primary Outcome Measures :
  1. Serum drug concentration levels of dexmedetomidine [ Time Frame: Up to 5 hours ]
    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.

  2. Time of peak drug concentration level of dexmedetomidine [ Time Frame: Up to 5 hours ]
    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.



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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417999


Contacts
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Contact: Kelly L Grogan, MD 410-279-6994 grogank@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Kelly L Grogan, MD    410-279-6994    grogank@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Kelly L Grogan, MD Children's Hospital of Philadelphia

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Responsible Party: Kelly Grogan, Attending Physician, Anesthesia and Critical Care Medicine, Principal Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03417999     History of Changes
Other Study ID Numbers: 17-014084
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly Grogan, Children's Hospital of Philadelphia:
Intranasal
Pharmacokinetic
Pediatric

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Congenital Abnormalities
Cardiovascular Abnormalities
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action