Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

Completed · Phase 1

Conditions studied: Heart Disease

In brief

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.

Key facts

Study ID

NCT02836431

Run by

Children's Hospital Medical Center, Cincinnati

People needed

18

Starts

2016-01-01

Expected to finish

2018-04-01

Last updated by the study team

2018-07-30

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

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. 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.

You may not qualify if…

• 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.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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