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临床试验/NCT01403363
NCT01403363Unknown不适用

Use of Fentanyl Patch in Partial Doses Than the Original

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
95
试验地点
1
主要终点
change of blood concentration levels of fentanyl and nurofentanyl

研究概览

简要总结

Fentanyl is considered a potent synthetic opioid widely used in anesthesiology, for short and long-term pain management, and for sedation. The fentanyl patch is constructed like a matrix, a system based on a polyacrylate net with fentanyl that attaches directly onto the skin. The doses available today are from 12µg/h, 25, 50, 75, to 100 µg/h. Despite the variable doses available, often in certain patients as the elderly or children, there is a need for slower titration than the 12 µg/h currently available.

In this study, the investigators aim to evaluate pain control and to examine the blood fentanyl concentration of patients on a fix dose of fentanyl patch up to 100 µg/h every two or three days, and compare it with pain control and concentration levels obtained from a similar dose patch, but after cutting the patch into two.

The study will take place at the pain clinic of Clalit Health Services-South District (CHS-SD), and the Negev home palliative care unit. In CHS-SD there are approximately 300 patients treated regularly with opioids and about 120 patients in the home palliative care unit. A sample of 95 patients will be recruited. Once consent form is signed, blood samples will be collected twice: 1. At the time of the visit; 2. After 144 hours (about 6 days) from the first sample, and at least 36 hours after replacing the cut patch. Pain management will be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI questionnaire, and rescue doses used before and after the cutting of the patch. The blood samples will be transferred to the laboratory for testing of fentanyl concentration levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •patients suffering from chronic pain on a fixed dose of fentanyl patch for over two weeks, with a maximum dose of 100 µg/h every two or three days, and have given their informed consent will be included in the study.

排除标准

  • •Patients with cognitive problems
  • •non-Hebrew speaking
  • •patients that their medical condition prevents them from participation in the study.

研究组 & 干预措施

fentanyl patch

Experimental

干预措施: use of fentanyl patch that was halved (Drug)

结局指标

主要结局

change of blood concentration levels of fentanyl and nurofentanyl

时间窗: 1. At the time of the visit; 2. After 144 hours (about 6 days) from the first sample, and at least 36 hours after replacing the cut patch

2 ml blood samples will be transferred under refrigerated conditions to the lab for a chromatography test using spectrometry testing for fentanyl and nurofentanyl. The change of blood concentration levels of fentanyl and nurofentanyl will be examined.

次要结局

  • Change of patients pain assessment(1. At the time of the visit; 2. After 144 hours (about 6 days) from the first sample, and at least 36 hours after replacing the cut patch)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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