Morphine Gel for Bedsores

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2003-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Decubitus Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pain relief for pressure ulcers

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No