Morphine Gel for Bedsores
Information source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Decubitus Ulcer
Intervention: Pain relief for pressure ulcers (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Official(s) and/or principal investigator(s):
Teresa D. Long, MD, Principal Investigator, Affiliation: The University of Kansas Medical Center
Summary
This study tests the effectiveness of a morphine-containing gel for reducing pain caused by
pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing
morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.
Clinical Details
Official title: Morphine-Infused Gel for Pressure Ulcer Analgesia
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed description:
In this study, we will apply a morphine-containing gel (or placebo) directly onto painful
pressure ulcers. We will take participants off of any opioid-containing medications upon
entry into the study. This allows us to measure any morphine that may enter into the
bloodstream from the topically applied gel.
The purpose of this study is to examine the efficacy of the gel for pressure ulcer analgesia,
as well as the systemic absorption of morphine from the topically applied gel. We will
document the amount of pain medications taken by participants to determine whether the gel
decreases the need for these drugs.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Presence of a Stage II pressure ulcer.
Pressure ulcer must be painful.
Primary Care physician must approve participation.
Thinking ability must be clear and intact.
Willing to change pain medication to oxycodone.
Exclusion Criteria:
Allergy to morphine, oxycodone or intrasite gel.
Use of codeine- or morphine-containing medications.
Use of pain medications for anything other than the pressure ulcer.
Locations and Contacts
The University of Kansas Medical Center, Kansas City, Kansas 66160, United States
Kindred Hospital, Kansas City, Missouri, United States
Additional Information
Related publications: Twillman RK, Long TD, Cathers TA, Mueller DW. Treatment of painful skin ulcers with topical opioids. J Pain Symptom Manage. 1999 Apr;17(4):288-92.
Starting date: March 2000
Ending date: February 2003
Last updated: January 2, 2007
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