Use of Fentanyl Patch in Partial Doses Than the Original

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meir Medical Center
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with cognitive problems

• non-Hebrew speaking

• patients that their medical condition prevents them from participation in the study.