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Morphine Gel for Bedsores

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007254
First Posted: December 18, 2000
Last Update Posted: May 20, 2013
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.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
University of Kansas Medical Center
  Purpose
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.

Condition Intervention Phase
Decubitus Ulcer Drug: Pain relief for pressure ulcers Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Morphine-Infused Gel for Pressure Ulcer Analgesia

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Estimated Enrollment: 75
Study Start Date: March 2000
Estimated Study Completion Date: February 2003
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007254


Locations
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Kindred Hospital
Kansas City, Missouri, United States
Sponsors and Collaborators
University of Kansas
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Teresa D. Long, MD The University of Kansas Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00007254     History of Changes
Other Study ID Numbers: R01AR045506 ( U.S. NIH Grant/Contract )
NIAMS-061
First Submitted: December 16, 2000
First Posted: December 18, 2000
Last Update Posted: May 20, 2013
Last Verified: May 2013

Keywords provided by University of Kansas Medical Center:
Analgesia
Bedsore
Morphine gel
Pressure ulcer
Pain
Ulcer

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents