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Use of Morphine Gel Topically in Patients With Stage 2-3 Wounds

Primary Purpose

Wounds

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
morphine topical gel
placebo
Sponsored by
Banner Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed and dated consent form & HIPAA
  • > 18 yo
  • Single stage 2-3 wound
  • No allergy to morphine
  • Alert and oriented (thinking ability clear and intact, physician approval)
  • English language proficiency

Exclusion Criteria:

  • Allergy to morphine, codeine, or versa base, pts taking medications for acute condition, other than for the wound pain
  • Patients with neuropathies
  • Patients with respiratory conditions

Sites / Locations

  • Banner Good Samaritan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

group to receive topical gel without morphine

Morphine gel

Outcomes

Primary Outcome Measures

Safety and efficacy with the use of morphine gel applied topically for pain control

Secondary Outcome Measures

Full Information

First Posted
September 18, 2008
Last Updated
September 18, 2008
Sponsor
Banner Health
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1. Study Identification

Unique Protocol Identification Number
NCT00755989
Brief Title
Use of Morphine Gel Topically in Patients With Stage 2-3 Wounds
Official Title
A Phase 3, Single-Centered, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Trial of Morphine Sulfate Gel 0.1% in Patients With Stage 2-3 Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Banner Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of oral and intravenous pain medications, therefore reducing side effects.
Detailed Description
Patients will be randomized to receive either placebo (versa base gel) or morphine gel to wound. Patients receiving morphine gel will have a decrease in pain score and use less oral/intravenous pain medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
group to receive topical gel without morphine
Arm Title
2
Arm Type
Experimental
Arm Description
Morphine gel
Intervention Type
Drug
Intervention Name(s)
morphine topical gel
Intervention Description
morphine gel 0.1%, applied every 12 hours to stage 2-3 wound, during their hospital stay
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
topical gel without morphine
Primary Outcome Measure Information:
Title
Safety and efficacy with the use of morphine gel applied topically for pain control
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated consent form & HIPAA > 18 yo Single stage 2-3 wound No allergy to morphine Alert and oriented (thinking ability clear and intact, physician approval) English language proficiency Exclusion Criteria: Allergy to morphine, codeine, or versa base, pts taking medications for acute condition, other than for the wound pain Patients with neuropathies Patients with respiratory conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Whitmer, FNP
Phone
602-239-6078
Email
marywhitmer@bannerhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Whitmer, MSN,FNP, APRN BC-PCM
Organizational Affiliation
Banner Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Whitmer
Phone
602-239-6078

12. IPD Sharing Statement

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Use of Morphine Gel Topically in Patients With Stage 2-3 Wounds

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