Clinical trial NCT02955732: Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients
Official title: Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Procedural Sedation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2016-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 1. The child is scheduled for intra-articular drug injections, hernia repair, bronchoscopy or another similar minor procedure or magnetic resonance imaging requiring sedation or anesthesia
* 2. Guardians and patient (if relevant) with fluent skills in the Finnish or Swedish language (to understand the given information, to be able to give informed consent and communicate with the study personnel).
* 3. Age between 1 month and 12 years.
* 4. Normal developmental status including growth (SD -1.5-1.5)
* 5. Written informed consent from the guardian and the patient (when relevant).

Exclusion Criteria:

* 1. A previous history of intolerance to the study drug or to related compounds and additives
* 2. Prior drug therapy with dexmedetomidine in the 14 days prior to the study.
* 3. Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed.
* 4. Existing or recent significant disease that could influence the study outcome or cause a health hazard for the subject if he/she would participate in the study.
* 5. Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* 6. Clinically significant abnormal findings in physical examination or laboratory screening \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].

Primary outcomes:
measure: Relative bioavailability (%) of intranasally given dexmedetomidine
timeFrame: 4 hours
Secondary outcomes:
measure: Change in hemodynamic parameter (blood pressure)
timeFrame: 6 hours
measure: Change in hemodynamic parameter (heart rate)
timeFrame: 6 hours
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: 6 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Study officials:
affiliation: Dept. Anaesthesilogy and Intensive Care, University of Turku and Turku University Hospital
name: Panu Uusalo, MD
role: PRINCIPAL_INVESTIGATOR
References: