NCT Number: NCT00007254
Morphine Gel for Bedsores
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
The University of Kansas Medical Center, Kansas City, Kansas, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
University of Kansas
Other
Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Registry information
Official study title
Morphine-Infused Gel for Pressure Ulcer Analgesia
Important dates
- Study start
- 2000
- Study completion
- 2003
- First posted
- Dec 18, 2000
- Registry last updated
- May 20, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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