Use of Fentanyl Patch in Partial Doses Than the Original
Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: use of fentanyl patch that was halved (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Meir Medical Center Official(s) and/or principal investigator(s): Pesach Shvartzman, MD, Principal Investigator, Affiliation: Clalit Health Services
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.
Clinical Details
Official title: Use of Fentanyl Patch in Partial Doses Than the Original
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: change of blood concentration levels of fentanyl and nurofentanyl
Secondary outcome: Change of patients pain assessment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pain clinic of Clalit Health Services-South District (CHS-SD), Beer-Sheva 84418, Israel
Additional Information
Starting date: March 2012
Last updated: June 14, 2015
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