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

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Dexmedetomidine

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