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| Name | Class |
|---|---|
| University of Turku | OTHER |
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We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or other procedures requiring sedation or anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal dex | Experimental | Dexmedetomidine 2-4 µg/kg alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Device | A 2-4 µg/kg dose of the study drug, 2 µg/kg of intranasal dexmedetomidine, will be administered using a LMA MAD Nasal™ -device approximately 20 min prior to planned sedation/anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability (%) of intranasally given dexmedetomidine | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemodynamic parameter (blood pressure) | More than 30% change from the baseline in the blood pressure (measured in mmHg) | 6 hours |
| Change in hemodynamic parameter (heart rate) | More than 30% change from the baseline in the heart rate (measured in beats per minute) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panu Uusalo, MD | Dept. Anaesthesilogy and Intensive Care, University of Turku and Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital | Turku | 20521 | Finland |
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|
| 6 hours |
| Number of patients with adverse events as a measure of safety and tolerability | 6 hours |