Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02955732
• Date of registration: 03/11/2016
• Prospective Registration: Yes
• Primary sponsor: Turku University Hospital
• Public title: Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients PINDEX
• Scientific title: Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children
• Date of first enrolment: January 1, 2017
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02955732
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Finland

Contacts

• Name: Panu Uusalo, MD
• Affiliation: Dept. Anaesthesilogy and Intensive Care, University of Turku and Turku University Hospital

Key inclusion & exclusion 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)].



Age minimum: 1 Month
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Procedural Sedation

Intervention(s)

Device: Dexmedetomidine

Primary Outcome(s)

Relative bioavailability (%) of intranasally given dexmedetomidine [Time Frame: 4 hours]

Secondary Outcome(s)

Number of patients with adverse events as a measure of safety and tolerability [Time Frame: 6 hours]

Change in hemodynamic parameter (blood pressure) [Time Frame: 6 hours]

Change in hemodynamic parameter (heart rate) [Time Frame: 6 hours]

Secondary ID(s)

T280/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Turku