Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients

NCT ID: NCT02955732

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-09-10

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.

Conditions

Procedural Sedation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intranasal dex

Dexmedetomidine 2-4 µg/kg alone

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Dexdor

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)].

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Panu Uusalo, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. Anaesthesilogy and Intensive Care, University of Turku and Turku University Hospital

Locations

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

T280/2016

Identifier Type: -

Identifier Source: org_study_id