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The Dex-Jet Study. Examining the effects of a sedative medication in healthy adult volunteers with a novel needle-free delivery device.

The Dex-Jet Study: Pharmacokinetics of needle-free jet injection of dexmedetomidine in healthy adult volunteers

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000547842
Acronym
Dex-Jet
Enrollment
10
Registered
2021-05-11
Start date
2021-12-04
Completion date
2021-12-04
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 100m

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.

Sponsors

Anaesthetic Research Department
Lead SponsorOther Collaborative groups

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Adult heathy volunteers

Exclusion criteria

Baseline heart rate of 45 or less Conduction issues on baseline ECG.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026