Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine

Not Applicable

Completed

• Conditions: Histamine; Isotonic Saline; Morphine; Cowhage
• Interventions: Drug: Morphine

• Registration Number: NCT04672382
• Lead Sponsor: Aalborg University

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.

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-17
• Study Start: 2021-07-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine	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), while two areas will be treated with injections of isotonic saline (0.05 ml, 0.9%) as vehicle. Fifteen minutes after the injections, the measurement of FLPI and wheal size will be conducted in one morphine and one saline treated area. This measurement will be followed by application of histamine and cowhage in the four areas (two pre-treated with morphine and two pre-treated with vehicle)

Primary Outcome Measures

Name	Time	Method
Measuring itch by computerized Visual Analog Scale Scoring	10 minutes	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".
Measuring pain by computerized Visual Analog Scale Scoring	10 minutes	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".
Superficial blood perfusion measurement	15 minutes	Superficial blood perfusion is measured by a Speckle contrast imager

Secondary Outcome Measures

Name	Time	Method
While size	15 minutes	While size will be assessed with a ruler

Trial Locations

Locations (1)

Silvia Lo Vecchio; 🇩🇰 Aalborg, Nordjylland, Denmark