Use of Fentanyl Patch in Partial Doses Than the Original
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
use of fentanyl patch that was halved
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility 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.
Sites / Locations
- Pain clinic of Clalit Health Services-South District (CHS-SD)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fentanyl patch
Arm Description
Outcomes
Primary Outcome Measures
change of blood concentration levels of fentanyl and nurofentanyl
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.
Secondary Outcome Measures
Change of patients pain assessment
Pain management will be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI questionnaire. We will examine the change of patients pain assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01403363
Brief Title
Use of Fentanyl Patch in Partial Doses Than the Original
Official Title
Use of Fentanyl Patch in Partial Doses Than the Original
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fentanyl patch
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
use of fentanyl patch that was halved
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of blood concentration levels of fentanyl and nurofentanyl
Description
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.
Time Frame
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
Secondary Outcome Measure Information:
Title
Change of patients pain assessment
Description
Pain management will be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI questionnaire. We will examine the change of patients pain assessment
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pesach Shvartzman, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain clinic of Clalit Health Services-South District (CHS-SD)
City
Beer-Sheva
ZIP/Postal Code
84418
Country
Israel
12. IPD Sharing Statement
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Use of Fentanyl Patch in Partial Doses Than the Original
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