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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Banner Health.
Recruitment status was:  Not yet recruiting
Information provided by:
Banner Health Identifier:
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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 Intervention Phase
Wounds Drug: morphine topical gel Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Banner Health:

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

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00755989

Contact: Mary Whitmer, FNP 602-239-6078

United States, Arizona
Banner Good Samaritan Medical Center Not yet recruiting
Phoenix, Arizona, United States, 85006
Contact: Whitmer    602-239-6078      
Sponsors and Collaborators
Banner Health
Principal Investigator: Mary Whitmer, MSN,FNP, APRN BC-PCM Banner Health
  More Information

Responsible Party: Mary Whitmer, MSN, FNP, APRN BC-PCM, Palliative care, Nursing Identifier: NCT00755989     History of Changes
Other Study ID Numbers: morphine gel
Study First Received: September 18, 2008
Last Updated: September 18, 2008

Additional relevant MeSH terms:
Wounds and Injuries
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on August 18, 2017