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临床试验/NCT00306020
NCT00306020撤回不适用

Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain

Soroka University Medical Center0 个研究点开始时间: 2006年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
pain intensity reports

研究概览

简要总结

Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified.

We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine.

Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe resting pain (scores above 5/10).
  • Stable analgesic regimen.
  • No surgical interventions planned during the study period.
  • Able to self-assess pain and report it.
  • Hospitalized or receiving home care for Stage I; out-patients or receiving home care for Stage II.
  • Wound not infected or covered with necrotic tissue.

排除标准

  • True sensitivity to opioids

结局指标

主要结局

pain intensity reports

frequency and type of side effects

blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide

次要结局

  • quantification of wound healing
  • change in use of regular analgesics

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pesach Shvartzman

Head-Department of Family Medicine

Soroka University Medical Center

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