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Morphine Gel for Bedsores

Primary Purpose

Decubitus Ulcer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pain relief for pressure ulcers
Sponsored by
University of Kansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decubitus Ulcer focused on measuring Analgesia, Bedsore, Morphine gel, Pressure ulcer, Pain, Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Kansas Medical Center
  • Kindred Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 16, 2000
Last Updated
May 17, 2013
Sponsor
University of Kansas
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00007254
Brief Title
Morphine Gel for Bedsores
Official Title
Morphine-Infused Gel for Pressure Ulcer Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kansas
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decubitus Ulcer
Keywords
Analgesia, Bedsore, Morphine gel, Pressure ulcer, Pain, Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pain relief for pressure ulcers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa D. Long, MD
Organizational Affiliation
The University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kindred Hospital
City
Kansas City
State/Province
Missouri
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10203881
Citation
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. doi: 10.1016/s0885-3924(98)00140-7.
Results Reference
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Morphine Gel for Bedsores

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