Morphine Gel for Bedsores

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007254
Recruitment Status : Completed
First Posted : December 18, 2000
Last Update Posted : May 20, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
University of Kansas Medical Center

December 16, 2000
December 18, 2000
May 20, 2013
March 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00007254 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Morphine Gel for Bedsores
Morphine-Infused Gel for Pressure Ulcer Analgesia
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.

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.

Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Decubitus Ulcer
Drug: Pain relief for pressure ulcers
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2003
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01AR045506( U.S. NIH Grant/Contract )
R01AR045506 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
University of Kansas
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Teresa D. Long, MD The University of Kansas Medical Center
University of Kansas Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP