Topical Morphine for Analgesia in Patients With Skin Grafts

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The management of pain endured by patients after skin grafting is complex. Pain is the single most distressing symptom but as it is difficult to manage, it is often under-treated. These patients may experience pain from two types of wound: the original injury and from "skin-donor" sites, areas of healthy skin from which skin is surgically removed and used to cover the original injury. As the section of skin which is removed is standardized, the wound created at the donor site is uniform and so provides a model of an acute wound.

Opioids (such as morphine) are the backbone of treating the moderate to severe pain experienced by any patient. But due to their potentially severe side effects and that some patients do not experience sufficient relief from the treatment, optimal treatment schedules are still being sought after.

Topically applied morphine has provided effective and safe analgesia in several clinical models. We, therefore, wish to apply this treatment modality onto skin-graft donor wounds. If found to be effective this could be an appealing non-invasive method to treat the pain of this type of wound.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Morphine

Criteria

Inclusion Criteria:

• Patients undergoing skin-grafting

• American Society of Anesthesiologists (ASA) classification I-II

• Written consent

• Either sex

• Able to self-asses and report their pain level

Exclusion Criteria:

• Alcohol abuse or addiction - current

• Opioids and benzodiazepines abuse - life time

• Known hypersensitivity to morphine

• Major renal or hepatic dysfunction

• Pregnancy or lactation

• Sleep-apnoea-syndrome

• Diabetes

• Participation in other clinical studies