Morphine Gel for Bedsores

Decubitus Ulcer Clinical Trial

Official title:

Morphine-Infused Gel for Pressure Ulcer Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007254
• Other study ID #: R01AR045506
• Secondary ID: R01AR045506NIAMS
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 16, 2000
• Last updated: May 17, 2013
• Start date: March 2000
• Est. completion date: February 2003

Study information

• Verified date: May 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Decubitus Ulcer
• Pressure Ulcer

Intervention

Drug:
• Pain relief for pressure ulcers

Locations

Country	Name	City	State
United States	Kindred Hospital	Kansas City	Missouri
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation