Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients

NCT02955732 | Completed Phase 4

• 1 other identifier: T280/2016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability (%) of intranasally given dexmedetomidine

  4 hours

Secondary Outcomes (3)

• Change in hemodynamic parameter (blood pressure)

  6 hours

• Change in hemodynamic parameter (heart rate)

  6 hours

• Number of patients with adverse events as a measure of safety and tolerability

  6 hours

Study Arms (1)

Intranasal dex

EXPERIMENTAL

Dexmedetomidine 2-4 µg/kg alone

Device: Dexmedetomidine

Interventions

Dexmedetomidine 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.

Also known as: Dexdor

Intranasal dex

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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
• \. 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).
• \. Age between 1 month and 12 years.
• \. Normal developmental status including growth (SD -1.5-1.5)
• \. Written informed consent from the guardian and the patient (when relevant).

You may not qualify if:

• \. A previous history of intolerance to the study drug or to related compounds and additives
• \. Prior drug therapy with dexmedetomidine in the 14 days prior to the study.
• \. 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.
• \. 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.
• \. Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
• \. Clinically significant abnormal findings in physical examination or laboratory screening \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

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

Turku, 20521, Finland

Location

Study Officials

• Panu Uusalo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 4, 2016
• Study Start: January 1, 2017
• Primary Completion: April 30, 2017
• Study Completion: September 10, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)