Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
Completed · Phase 1
Conditions studied: Heart Diseases
In brief
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.
Key facts
- Study ID
- NCT03668951
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 18
- Starts
- 2018-08-20
- Expected to finish
- 2022-05-03
- Last updated by the study team
- 2023-02-08
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 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
Where it is running
- Joanna Paquin — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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