Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University
Gistrup, Aalborg, 9260, Denmark
NCT Number: NCT06245564
Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treat-ment options for chronic itch. Topical ketamine cream has been used successfully to relieve various forms of pain, and we hypothesize that topical ketamine relieves itch through a mechanism of action comparable to that in pain relief.
The aim of this project is to evaluate the effects of ketamine both alone and in combination with amitriptyline on histaminergic and non-histaminergic itch induced by histamine and cowhage, respectively.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Gistrup, Aalborg, 9260, Denmark
The main action of ketamine, 2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone, is to antagonize the glutamate N-methyl-D-aspartate (NMDA) receptors. In the clinical setting, topical ketamine cream has been used successfully to relieve various pathogenic forms of pain. In addition to its pain-relieving effects, the cream was also reported to have itch-relieving properties in a very limited study. However, its efficacy on itch has not been established, and the mechanism of action remains uncertain. Ketamine cream is used not only by itself, but also in conjunction with other analgesics. One of these is amitriptyline, which may enhance the analgesic effects of ketamine. The aim of this human experimental study is to use the well-characterized anesthetic Ketamine, both alone and in combination with amitriptyline, as a tool to modulate different histaminergic and non-histaminergic itch modalities evoked by histamine and cowhage.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ketamine cream 0.5% will be applied in a 4x4 area in the forearm of each participant.
Amitriptyline cream 1% will be applied in a 4x4 area in the forearm of each participant.
A cream containing ketamine 0.5%, amitriptyline 1%, will be applied in a 4x4 area in the forearm of each participant.
A vehicle cream will be applied in a 4x4 area in the forearm of each participant.
After the cream removal, itch will be induced using histamine in the first session
After the cream removal, itch will be induced using cowhage in the second session
Time frame: Immediately after the intervention
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
Time frame: Immediately after the intervention
We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Time frame: Immediately after the intervention
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Time frame: Immediately after the intervention
Pleasant touch sensation measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Time frame: Immediately after the intervention
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Time frame: Immediately after the intervention
The von-Frey filament that better evokes the itch sensation during the assessment of mechanically evoked itch as well as a template of soft plastic are used to map the area of hyperkinesis in the test areas (forearms).
Time frame: Immediately after the intervention
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Time frame: Immediately after the intervention
This test is conducted with the same pinprick set used to test the MPT.
Time frame: Immediately after the intervention
The pinprick that was selected in the MPT as well as a template of soft plastic are used to map the area of hyperalgesia in the test areas (forearms).
Time frame: Immediately after the intervention
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Time frame: Immediately after the intervention
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Time frame: Immediately after the intervention
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Time frame: Immediately after the intervention
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Time frame: Immediately after the intervention
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Aalborg University
Other
Effect of Ketamine, Amitriptyline and Their Combination on Histaminergic and Non-histaminergic Itch
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