Paediatric patients scheduled for minor procedures such as intra-articular drug injections, hernia repair, bronchoscopy or magnetic resonance imaging.
Conditions
Interventions
Trade Name: Dexdor
Pharmaceutical Form: Infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
University of Turku
Eligibility
Sex/Gender
All
Inclusion 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 patients (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). Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to characterize the pharmacokinetics of dexmedetomidine after intranasal dosing.;Secondary Objective: We will also monitor the haemodynamic effects, local and systemic safety and local tolerability of intranasally administered dexmedetomidine;Primary end point(s): The bioavailability of intranasally given dexmedetomidine in children as characterized against previously available intravenous study data;Timepoint(s) of evaluation of this end point: 24 h after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The pharmacokinetics and –dynamics of intranasally given dexmedetomidine in children. ;Timepoint(s) of evaluation of this end point: 24 h after administration | — |
Countries
Finland
Contacts
Public ContactTurku Clinical Research Centre
Turku University Hospital
Outcome results
None listed