Topical Morphine for Analgesia in Patients With Skin Grafts
NCT ID: NCT00362219
Last Updated: 2022-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2022-01-31
2024-12-31
Brief Summary
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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.
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Detailed Description
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Peripheral analgesic effects of opioids are not detectable in normal tissue but appear minutes to hours after initiation of inflammation. This suggests that opioid receptors are already present in the peripheral nerve terminals but under normal conditions they are not functional.
Research on application of opioids to skin wounds is very sparse and has primarily been performed in palliative care patients. These reports demonstrate that topical opioid gel (morphine or diamorphine) provided rapid and effective relief. In some patients pain subsided within 20 minutes after application with a long-lasting (7-8 hours) effect. Fundamental aspects regarding topical application of opioids onto skin wounds are still lacking. For example, issues such as optimal dose and dose-effect relationships have not been investigated. We hope to determine these in this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Gel with no active ingredient
Placebo
Gel with no active ingredient.
Morphine .25 mg
Gel with 0.25 mg morphine per 100cm2 square of wound
Morphine - .25 mg
gel with 0.25 mg morphine per 100cm2 square of wound.
Morphine - .75 mg.
Gel with 0.75 mg morphine per 100cm2 square of wound.
Morphine
Gel with 0.75 mg morphine per 100cm2 square of wound.
Morphine 1.25 mg.
Gel with 1.25 mg morphine per 100cm2 square of wound.
Morphine
Gel with 1.25 mg morphine per 100cm2 square of wound.
Interventions
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Placebo
Gel with no active ingredient.
Morphine - .25 mg
gel with 0.25 mg morphine per 100cm2 square of wound.
Morphine
Gel with 0.75 mg morphine per 100cm2 square of wound.
Morphine
Gel with 1.25 mg morphine per 100cm2 square of wound.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) classification I-II
* Written consent
* Either sex
* Able to self-asses and report their pain level
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Yehuda Ullmann MD
Head, Plastic Surgery Department
Principal Investigators
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Yehuda Ullman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Department of Plastic Surgery, Rambam Medical Center
Haifa, , Israel
Countries
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References
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Krajnik M, Zylicz Z, Finlay I, Luczak J, van Sorge AA. Potential uses of topical opioids in palliative care--report of 6 cases. Pain. 1999 Mar;80(1-2):121-5. doi: 10.1016/s0304-3959(98)00211-5.
Stein C, Comisel K, Haimerl E, Yassouridis A, Lehrberger K, Herz A, Peter K. Analgesic effect of intraarticular morphine after arthroscopic knee surgery. N Engl J Med. 1991 Oct 17;325(16):1123-6. doi: 10.1056/NEJM199110173251602.
Porzio G, Aielli F, Verna L, Cannita K, Marchetti P, Ficorella C. Topical morphine in the treatment of painful ulcers. J Pain Symptom Manage. 2005 Oct;30(4):304-5. doi: 10.1016/j.jpainsymman.2005.08.011. No abstract available.
Ribeiro MD, Joel SP, Zeppetella G. The bioavailability of morphine applied topically to cutaneous ulcers. J Pain Symptom Manage. 2004 May;27(5):434-9. doi: 10.1016/j.jpainsymman.2003.09.011.
Stein A, Yassouridis A, Szopko C, Helmke K, Stein C. Intraarticular morphine versus dexamethasone in chronic arthritis. Pain. 1999 Dec;83(3):525-532. doi: 10.1016/S0304-3959(99)00156-6.
Zeppetella G, Ribeiro MD. Morphine in intrasite gel applied topically to painful ulcers. J Pain Symptom Manage. 2005 Feb;29(2):118-9. doi: 10.1016/j.jpainsymman.2004.12.006. No abstract available.
Stein C, Schafer M, Machelska H. Attacking pain at its source: new perspectives on opioids. Nat Med. 2003 Aug;9(8):1003-8. doi: 10.1038/nm908.
Other Identifiers
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RMC-2468.CTIL
Identifier Type: -
Identifier Source: org_study_id
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