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

NCT03668951 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2018-3034
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

Pediatric; Sedation; Dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• Maximum blood concentration level of Dex - Cmax

  Dex concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax).

  Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .

• The amount of time that Dex is present at the maximum concentration - Tmax

  Dex concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts.

  Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .

Secondary Outcomes (5)

• Area under the curve for Dex concentration levels

  Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .

• Bioavailability of intranasal Dex relative to intravenous Dex for distribution - plasma concentration

  Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .

• Bioavailability of IN Dex relative to intravenous Dex for elimination - plasma concentration.

  Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .

• Adverse events associated with Dex administration

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

• Systolic and diastolic blood pressure with Dex administration

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

Study Arms (3)

Buccal DEX 2 mcg/kg

EXPERIMENTAL

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

Intranasal DEX 3 mcg/kg

EXPERIMENTAL

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

Intranasal DEX 4 mcg/kg

EXPERIMENTAL

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

Interventions

Dexmedetomidine buccal DRUG

DEX 2 mcg/kg buccal

Buccal DEX 2 mcg/kg

Dexmedetomidine Intranasal DRUG

DEX 3 mcg/kg intranasal

Intranasal DEX 3 mcg/kg

Eligibility Criteria

• Age: 6 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Joanna Paquin

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Jayant Pratap, MA,MB BChir,MRCPCH,FRCA

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 13, 2018
• Study Start: August 20, 2018
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)