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
Anaesthetic Research Department
10 participants
Dec 4, 2021
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Adult heathy volunteers
Exclusion Criteria2
- Baseline heart rate of 45 or less
- Conduction issues on baseline ECG.
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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 100mcg in the second half of the volunteers.
Locations(1)
View Full Details on ANZCTR
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ACTRN12621000547842