Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients (PINDEX)

Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children

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.

Study Overview

• Status: Completed
• Conditions: Procedural Sedation
• Intervention / Treatment: Device: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20521
    • Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal dex; Dexmedetomidine 2-4 µg/kg alone	Device: 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.; Other Names: Dexdor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative bioavailability (%) of intranasally given dexmedetomidine	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemodynamic parameter (blood pressure)	More than 30% change from the baseline in the blood pressure (measured in mmHg)	6 hours
Change in hemodynamic parameter (heart rate)	More than 30% change from the baseline in the heart rate (measured in beats per minute)	6 hours
Number of patients with adverse events as a measure of safety and tolerability		6 hours

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Turku
• Investigators: Principal Investigator: Panu Uusalo, MD, Dept. Anaesthesilogy and Intensive Care, University of Turku and Turku University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: T280/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO