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Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine

Effect of Intradermal Morphine Application on Histaminergic and Non-histaminergic Itch and Related TRPV1 and Antihistamine Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04672382
Enrollment
26
Registered
2020-12-17
Start date
2021-07-01
Completion date
2022-12-31
Last updated
2023-01-18

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

Conditions

Cowhage, Histamine, Isotonic Saline, Morphine

Brief summary

The aim of this study is to the effect of opioid (morphine) intradermal application on histaminergic and non-histaminergic itch. In particular, we would like to demonstrate that also peripheral administration of morphine may affect mast cell release of histamine.

Detailed description

Opioids (i.e. substances extracted from opium poppies, e.g. morphine) are used for treatment of both acute and chronic pain conditions as well as in surgical procedures. Opioids render effective pain relief, however, they may cause bothersome itch as a side effect. With this series of experiments, we wish to clarify how an injection with morphine in the skin layer called dermis (located right below the upper skin) will affect itch.

Interventions

DRUGMorphine

During the 1st session, each of the middle forearms of the subject will be divided into two squared areas (4x4 cm) located 3 cm apart. Two areas will be treated with an intradermal injection of morphine (0.05 ml, 0.1 mg/ml), and two areas with an intradermal injection of isotonic saline.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy men and women * 18-60 years * Speak and understand English

Exclusion criteria

* Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results. * Pregnancy or lactation * Drug addiction defined as any use of cannabis, opioids or other addictive drugs * Lack of ability to cooperate * Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids. * Participants with known allergy/discomfort to the opioid morphine and antihistamine. * Skin diseases * Moles, scars or tattoos in the area to be treated or tested. * Consumption of alcohol or painkillers 24 hours before the study days and between these * Acute or chronic pain * Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Design outcomes

Primary

MeasureTime frameDescription
Measuring itch by computerized Visual Analog Scale Scoring10 minutesWe 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.
Measuring pain by computerized Visual Analog Scale Scoring10 minutesWe 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.
Superficial blood perfusion measurement15 minutesSuperficial blood perfusion is measured by a Speckle contrast imager

Secondary

MeasureTime frameDescription
While size15 minutesWhile size will be assessed with a ruler

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026