Morphine Gel for Bedsores

This study has been completed.

First Received on December 16, 2000. Last Updated on January 2, 2007 History of Changes

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00007254

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 I Phase II

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 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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

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:

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.

ClinicalTrials.gov Identifier:	NCT00007254 History of Changes
Other Study ID Numbers:	R01 AR45506, NIAMS-061
Study First Received:	December 16, 2000
Last Updated:	January 2, 2007
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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 February 12, 2012