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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Turku, Finland
Relative bioavailability (%) of intranasally given dexmedetomidine
Time frame: 4 hours
Change in hemodynamic parameter (blood pressure)
More than 30% change from the baseline in the blood pressure (measured in mmHg)
Time frame: 6 hours
Change in hemodynamic parameter (heart rate)
More than 30% change from the baseline in the heart rate (measured in beats per minute)
Time frame: 6 hours
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 6 hours
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