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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755989
Recruitment Status : Unknown
Verified September 2008 by Banner Health.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
Sponsor:
Information provided by:
Banner Health

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.

Condition or disease Intervention/treatment Phase
Wounds Drug: morphine topical gel Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1
group to receive topical gel without morphine
Drug: placebo
topical gel without morphine

Experimental: 2
Morphine gel
Drug: morphine topical gel
morphine gel 0.1%, applied every 12 hours to stage 2-3 wound, during their hospital stay




Primary Outcome Measures :
  1. Safety and efficacy with the use of morphine gel applied topically for pain control [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755989


Contacts
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Contact: Mary Whitmer, FNP 602-239-6078 marywhitmer@bannerhealth.com

Locations
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United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Contact: Whitmer    602-239-6078      
Sponsors and Collaborators
Banner Health
Investigators
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Principal Investigator: Mary Whitmer, MSN,FNP, APRN BC-PCM Banner Health

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Responsible Party: Mary Whitmer, MSN, FNP, APRN BC-PCM, Palliative care, Nursing
ClinicalTrials.gov Identifier: NCT00755989    
Other Study ID Numbers: morphine gel
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Wounds and Injuries
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents