Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000547842
Ethics application status
Approved
Date submitted
5/03/2021
Date registered
11/05/2021
Date last updated
13/05/2022
Date data sharing statement initially provided
11/05/2021
Date results information initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Dex-Jet Study.
Examining the effects of a sedative medication in healthy adult volunteers with a novel needle-free delivery device.
Scientific title
The Dex-Jet Study: Pharmacokinetics of needle-free jet injection of dexmedetomidine in healthy adult volunteers
Secondary ID [1] 303613 0
Nil other
Universal Trial Number (UTN)
U1111-1266-1585
Trial acronym
Dex-Jet
Linked study record
Not linked

Health condition
Health condition(s) or problem(s) studied:
Needle Phobia 320987 0
Anxiety before an operation 321759 0
Condition category
Condition code
Anaesthesiology 318793 318793 0 0
Anaesthetics
Mental Health 319187 319187 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexmeditomidine. Single dose.
The medication will be given through the skin and into the muscle in the arm using a jet propulsion device. The device is placed on the arm and once triggered takes less than 1 second to administer the medication into the muscle in the arm.
Initially a dose of 50mcg of Jet injected Dexmedetomidine will be administered to the first 5 volunteers. Once the plasma levels from 50mcg dose are known a decision will be made to continue with 50mcg or increased dose to 100mcg in the second half of the volunteers.
Intervention code [1] 319898 0
Treatment: Drugs
Intervention code [2] 319899 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326738 0
Plasma concentrations of dexmeditomidine.
Cmax, Tmax, AUC and T1/2.
Timepoint [1] 326738 0
5 venous blood samples (about 2ml) will be obtained from the IV cannula or venepuncture at: 3-5 mins, 7-15 mins, 20-40 mins, 1-1.2hour, and 4-6 hour after the injection of dexmeditomidine
Secondary outcome [1] 392529 0
pain on injection using a standard 1 to 10 numerical pain rating scale- before and directly after medication administration.
Timepoint [1] 392529 0
24hours
Baseline- prior to administration
Immediately after administration and 1 hour after administration
Phone call the following day.
Secondary outcome [2] 393656 0
Local Site Effects
Examination of the site of injection for signs of tissue damage.
Timepoint [2] 393656 0
24 hours
Site will be assessed directly after administration, 1 hour after administration.
Participants will be called the following day to assess the site.

Eligibility
Key inclusion criteria
Adult heathy volunteers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Baseline heart rate of 45 or less
Conduction issues on baseline ECG.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
We will have the plasma dexmedetomidine concentrations and times for a total of 50 samples from 10 subjects. Following routine 3 compartment mammillary pharmacokinetic nonlinear mixed effects models, we would expect to establish the estimation of the model parameters with comparable accuracy to previous published pharmacokinetic models of dexmedetomidine – and hence be able to do acceptable comparisons

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2021
Actual
4/12/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
4/12/2021
Date of last data collection
Anticipated
30/06/2022
Actual
5/12/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 23498 0
New Zealand
State/province [1] 23498 0
Waikato

Funding & Sponsors
Funding source category [1] 308033 0
Hospital
Name [1] 308033 0
Anaesthetic research department- Waikato hospital,
Country [1] 308033 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Anaesthetic Research Department
Address
Waikato District Health Board
Waikato Hospital
Waiora Building Level 4
Pembroke St
Hamilton 3240
New Zealand
Country
New Zealand
Secondary sponsor category [1] 308756 0
None
Name [1] 308756 0
N/A
Address [1] 308756 0
N/A
Country [1] 308756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308027 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308027 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 308027 0
New Zealand
Date submitted for ethics approval [1] 308027 0
29/04/2021
Approval date [1] 308027 0
07/10/2021
Ethics approval number [1] 308027 0
21/STH/212

Summary
Brief summary
Everyone knows someone who is scared to go to the doctor or dentist because they are scared of needles. “Needle phobia” is very common and can lead to people avoiding important healthcare and treatments. Therefore, a needle free injection of sedative pain relief could relieve this anxiety in vulnerable population groups. Improving ability of some groups such as children and those with intellectual disabilities and dementia to access healthcare. Making healthcare more pleasant for everyone of all age groups.
The study will aim to show that giving a sedative medication to healthy adult volunteers is not painful, is safe and is effective in achieving sedation effects similar to when the medication is given in other ways- for example through the nose.

Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 109266 0
Dr Nicola Whittle
Address 109266 0
Waikato District Health Board
Waikato Hospital
Waiora Buidling Level 4
Pembroke st 3240
Hamilton
New Zealand
Country 109266 0
New Zealand
Phone 109266 0
+64 21455305
Fax 109266 0
Email 109266 0
Nicola.whittle@waikatodhb.health.nz
Contact person for public queries
Name 109267 0
Mr Jono Termaat
Address 109267 0
Waikato District Health Board
Waikato Hospital
Waiora Buidling Level 4
Anaesthetic Research department
Pembroke st 3240
Hamilton
New Zealand
Country 109267 0
New Zealand
Phone 109267 0
+64 27 4031939
Fax 109267 0
N/A
Email 109267 0
jonathan.termaat@waikatodhb.health.nz
Contact person for scientific queries
Name 109268 0
Dr Nicola Whittle
Address 109268 0
Waikato District Health Board
Waikato Hospital
Waiora Buidling Level 4
Anaesthetic Research department
Pembroke st 3240
Hamilton
Country 109268 0
New Zealand
Phone 109268 0
+64 21455305
Fax 109268 0
Email 109268 0
Nicola.whittle@waikatodhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data- all of the data collected for the trial.
When will data be available (start and end dates)?
After publication with no end date
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to PI approval
Nicola.Whittle@waikatodhb.health.nz


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4854Study results articleYes Publication1_whittle-et-al-2023-preliminary-pharmacokinetics-and-patient-experience-of-jet-injected-dexmedetomidine-in-healthy-adu.pdf

Documents added automatically
No additional documents have been identified.