Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Banner Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Banner Health
ClinicalTrials.gov Identifier:
NCT00755989
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT00755989

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

Locations
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
Investigators
Principal Investigator: Mary Whitmer, MSN,FNP, APRN BC-PCM Banner Health
  More Information

No publications provided

Responsible Party: Mary Whitmer, MSN, FNP, APRN BC-PCM, Palliative care, Nursing
ClinicalTrials.gov Identifier: NCT00755989     History of Changes
Other Study ID Numbers: morphine gel
Study First Received: September 18, 2008
Last Updated: September 18, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014