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| Sponsored by: |
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 |
| MedlinePlus related topics: | Pressure Sores |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Morphine-Infused Gel for Pressure Ulcer Analgesia |
| Estimated Enrollment: | 75 |
| Study Start Date: | March 2000 |
| Estimated Study Completion Date: | February 2003 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| Principal Investigator: | Teresa D. Long, MD | The University of Kansas Medical Center |
More Information
| Study ID Numbers: | R01 AR45506, NIAMS-061 |
| First Received: | December 16, 2000 |
| Last Updated: | January 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00007254 |
| Health Authority: | United States: Federal Government |
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