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Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children (DexPK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668951
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.

Condition or disease Intervention/treatment Phase
Heart Diseases Drug: Dexmedetomidine buccal Drug: Dexmedetomidine Intranasal Phase 1

Detailed Description:

The study will be a prospective study of plasma concentrations after intranasal or buccal DEX to determine the early pharmacokinetics and bioavailability of a single dose via nasal or oral administration.

Dexmedetomidine sedation is commonly used at Cincinnati Children's Medical Center and other pediatric institutions. This compound is typically delivered intravenously or intranasally for sedation in children with or without congenital heart disease. Intranasal DEX is very effective for sedation although it has significant variability in the onset and peak effect. Patient care will be improved if factors that determine this variability can be determined. Investigators will determine the important clinical variables of peak plasma DEX concentration (Tmax and Cmax) of intranasal and buccal DEX in children.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buccal DEX 2 mcg/kg
Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia, placement of an endotracheal tube and an arterial line. Once these are accomplished, Dexmedetomidine is administered according to group assignment.
Drug: Dexmedetomidine buccal
DEX 2 mcg/kg buccal

Experimental: Intranasal DEX 3 mcg/kg
Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia, placement of an endotracheal tube and an arterial line. Once these are accomplished, Dexmedetomidine is administered according to group assignment.
Drug: Dexmedetomidine Intranasal
DEX 3 mcg/kg intranasal

Experimental: Intranasal DEX 4 mcg/kg
Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia, placement of an endotracheal tube and an arterial line. Once these are accomplished, Dexmedetomidine is administered according to group assignment.
Drug: Dexmedetomidine Intranasal
DEX 4 mcg/kg intranasal




Primary Outcome Measures :
  1. Maximum blood concentration level of Dex - Cmax [ Time Frame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . ]
    Dex concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax).

  2. The amount of time that Dex is present at the maximum concentration - Tmax [ Time Frame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . ]
    Dex concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts.


Secondary Outcome Measures :
  1. Area under the curve for Dex concentration levels [ Time Frame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . ]
    Dex concentration will be measured in the blood samples.

  2. Bioavailability of intranasal Dex relative to intravenous Dex for distribution - plasma concentration [ Time Frame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . ]
    Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators will be measuring for approximately one half-life of Dex. This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex.

  3. Bioavailability of IN Dex relative to intravenous Dex for elimination - plasma concentration. [ Time Frame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . ]
    Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators will be measuring for approximately one half-life of Dex. This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex.

  4. Adverse events associated with Dex administration [ Time Frame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours. ]
    Heart rate will be recorded by clinical staff prior to the procedure and continuously during the procedure. The heart rate during the time of study blood collection will be compared to the baseline vitals to determine is any adverse events occurred.

  5. Systolic and diastolic blood pressure with Dex administration [ Time Frame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours. ]
    Systolic and diastolic blood pressure will be recorded by clinical staff prior to the procedure and continuously during the procedure. The systolic and diastolic blood pressure during the time of study blood collection will be compared to the baseline blood pressure to determine is any adverse events occurred.



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Ages Eligible for Study:   6 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery
  • The subject must be a candidate to receive Dex as determined by one of the study cardiac anesthesiologists
  • The attending cardiac anesthesiologists for the case and the Chief of Anesthesia Cardiac Anesthesia will concur with or veto this decision
  • The subjects legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

  • Post-natal age less than 6 months
  • The subject is allergic to or has had a contraindication to Dex
  • Severely depressed ventricular function on preoperative echocardiogram
  • The subject has a high risk of cardiac conduction system disease in the judgement of the attending anesthesiologist or cardiologist
  • The subject has a hemodynamically significant aortic coarctation or other left heart outflow obstruction
  • The subject has received digoxin, beta-adrenergic antagonist, or calcium channel antagonist on the day of surgery
  • The subject has received Dex within 1 week of the study date
  • Patients who are to receive intranasal Dex are excluded if they have nasal/respiratory symptoms, which in the opinion of the study anesthesiologist, may affect intranasal drug absorption

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): NCT03668951


Contacts
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Contact: Jayant Pratap, MA,MB BChir,MRCPCH,FRCA 513-803-3793 jayant.pratap@cchmc.org
Contact: Kristie Geisler, BS, CCRP 513-636-3282 kristie.geisler@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jayant Pratap, MA, MB BChir, MRCPCH, FRCA    513-803-3793    jayant.pratap@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jayant Pratap, MA,MB BChir,MRCPCH,FRCA Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03668951    
Other Study ID Numbers: 2018-3034
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
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 Children's Hospital Medical Center, Cincinnati:
Pediatric
Sedation
Dexmedetomidine
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
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