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Morphine Gel for Bedsores

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00007254
First received: December 16, 2000
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Morphine-Infused Gel for Pressure Ulcer Analgesia

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by University of Kansas:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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: R01 AR45506, R01AR045506, NIAMS-061
Study First Received: December 16, 2000
Last Updated: May 17, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 21, 2013