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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.
The study will be a prospective study of plasma concentrations after intranasal or buccal DEX to determine the early pharmacokinetics and bioavailability of a single dose via nasal or oral administration.
Dexmedetomidine sedation is commonly used at Cincinnati Children's Medical Center and other pediatric institutions. This compound is typically delivered intravenously or intranasally for sedation in children with or without congenital heart disease. Intranasal DEX is very effective for sedation although it has significant variability in the onset and peak effect. Patient care will be improved if factors that determine this variability can be determined. Investigators will determine the important clinical variables of peak plasma DEX concentration (Tmax and Cmax) of intranasal and buccal DEX in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine buccal | Drug | DEX 2 mcg/kg buccal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for Dex concentration levels | Dex concentration will be measured in the blood samples. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayant Pratap, MA,MB BChir,MRCPCH,FRCA | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joanna Paquin | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Dexmedetomidine Intranasal |
| Drug |
DEX 3 mcg/kg intranasal |
|
| Dexmedetomidine Intranasal | Drug | DEX 4 mcg/kg intranasal |
|
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators will be measuring for approximately one half-life of Dex. This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex. |
| 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. | Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators will be measuring for approximately one half-life of Dex. This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex. | 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 | Heart rate will be recorded by clinical staff prior to the procedure and continuously during the procedure. The heart rate during the time of study blood collection will be compared to the baseline vitals to determine is any adverse events occurred. | Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours. |
| Systolic and diastolic blood pressure with Dex administration | Systolic and diastolic blood pressure will be recorded by clinical staff prior to the procedure and continuously during the procedure. The systolic and diastolic blood pressure during the time of study blood collection will be compared to the baseline blood pressure to determine is any adverse events occurred. | Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours. |