Trials / Completed
CompletedNCT02955732
Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients
Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Turku University Hospital · Other Government
- Sex
- All
- Age
- 1 Month – 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dexmedetomidine | 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. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2017-04-30
- Completion
- 2018-09-10
- First posted
- 2016-11-04
- Last updated
- 2018-09-12
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT02955732. Inclusion in this directory is not an endorsement.