Skip to main content
OpenTrials
Completed

NCT Number: NCT02836431

Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

6 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

The study will be a prospective study of plasma concentrations after intranasal (1 µg/kg and 2µg/kg) and intravenous (1 µg /kg) DEX to determine the early pharmacokinetics (maximum concentration (peak) and time to peak) and bioavailability of a single intranasal dose in pediatric patients.

Dexmedetomidine sedation is commonly utilized at Cincinnati Children's Medical Center (CCHMC) and other pediatric institutions. This compound is delivered intravenously or intranasally for sedation in children with and without congenital heart disease. Intranasal DEX, though very effective for sedation, has significant variability in its onset and peak effect. Patient care will be significantly improved if factors that determine this variability in onset and peak effect can be determined. Investigators will determine the important early clinical variables of peak plasma DEX concentration (Tmax and Cmax) and the 0 - 2 hour bioavailability of intranasal DEX in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. A physician member of the Division of Cardiac Anesthesiology, not involved in the study, will make this decision.
  • The subject's legally authorized representative has given written informed consent to participate in the study.

Exclusion criteria

  • Post-natal age (PNA) < 6 months
  • The subject is allergic to or has a contraindication to DEX
  • Severely depressed ventricular function (ejection fraction 30% or less) on preoperative echocardiogram
  • The subject has high risk cardiac conduction system disease at the discretion of the attending anesthesiologist or cardiologist.
  • The subject has a hemodynamically significant coarctation or other left heart outflow obstruction
  • The subject has received digoxin, beta-adrenergic antagonist, or calcium-channel antagonist on the day of the study
  • The subject has received DEX within 1 week of the study date (information obtained from: parent or Medical record)
  • Subject have nasal/respiratory symptoms which in the opinion of the Principal investigator, may affect intranasal drug absorption.

Treatment and study plan

Dexmedetomidine 1mcg/kg Intranasal

Drug

DEX 1 mcg/kg Intranasal

Dexmedetomidine 2mcg/kg Intranasal

Drug

DEX 2 mcg/kg Intranasal

Dexmedetomidine 1mcg Intravenous

Drug

DEX 1 mcg/kg Intravenously

Primary outcomes

  1. Maximum blood concentration level of DEX - Cmax

    Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours

    DEX concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.

  2. The amount of time that a DEX is present at the maximum concentration - Tmax

    Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours

    DEX concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts (Tmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.

  3. Area under the curve for DEX concentration levels

    Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours

    DEX concentration will be measured in the blood samples. Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.

  4. Bioavailability of intranasal DEX relative to intravenous DEX for distribution - plasma concentration

    Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours

    Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring distribution for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX.

  5. Bioavailability of intranasal DEX relative to intravenous DEX for elimination - plasma concentration

    Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours

    Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring elimination for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX.

Secondary outcomes

  1. Adverse events associated with DEX administration

    Time frame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.

    Heart rate and blood pressure are recorded by clinical staff prior to the procedure and continuously during the procedure. The heart rate and blood pressure during the time of study blood collection will be compared to the baseline vitals to determine if any adverse events occurred.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.