Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients

Procedural Sedation Clinical Trial

— PINDEX  

Official title:

Bioavailability and Pharmacokinetics of Intranasal Dexmedetomidine in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955732
• Other study ID #: T280/2016
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: September 2018
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 10, 2018
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

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)].

Related Conditions & MeSH terms

• Procedural Sedation

Intervention

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.

Locations

Country	Name	City	State
Finland	Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability (%) of intranasally given dexmedetomidine		4 hours
Secondary	Change in hemodynamic parameter (blood pressure)	More than 30% change from the baseline in the blood pressure (measured in mmHg)	6 hours
Secondary	Change in hemodynamic parameter (heart rate)	More than 30% change from the baseline in the heart rate (measured in beats per minute)	6 hours
Secondary	Number of patients with adverse events as a measure of safety and tolerability		6 hours