Pressure ulcers are a common problem for immobilized patients of all ages, and for several distinct patient populations including the elderly and debilitated. These sores are often very painful, yet little analgesic research has been conducted in this area. Most physicians undertreat the pain associated with pressure ulcers as they take a fairly long time to heal, and typically occur comorbidly with peripheral, cardiac, cerebral vascular disease, renal dysfunction and old age. Placing patients on an opiate-containing substance, alone, or in addition to other medications, with its attendant side-effects, is an unattractive prospect. Research has been conducted on the binding of topical opioids to receptors on the sensory nerve terminals located at the periphery. Peripheral analgesia has been used extensively in arthroscopic knee surgeries and painful skin lesions. The investigator has used topical opioids clinically, and reports on eight cases. These patients' pain was effectively treated with morphine infused IntraSite(R) gel (MIG) applied to pressure ulcers at the time of dressing changes, with no opioid side-effects reported. A double-blind, placebo-controlled study is needed at this time to evaluate the safety and efficacy of MIG. The proposed study is a randomized double-blind study of MIG versus placebo over a two week period. Efficacy will be measured by pain ratings and controlled tracking of concomitant medications. Safety will be assessed by the severity of opioid side-effects and the amount of morphine absorbed systemically. In addition, interference with daily functioning, wound healing, and onset and duration of analgesia s/p application of MIG will be assessed.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
1R01AR045506-01A2
Application #
6045353
Study Section
Surgery, Anesthesiology and Trauma Study Section (SAT)
Program Officer
Moshell, Alan N
Project Start
2000-03-01
Project End
2002-02-28
Budget Start
2000-03-01
Budget End
2001-02-28
Support Year
1
Fiscal Year
2000
Total Cost
$239,708
Indirect Cost
Name
University of Kansas
Department
Psychiatry
Type
Schools of Medicine
DUNS #
016060860
City
Kansas City
State
KS
Country
United States
Zip Code
66160