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

Wounds Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00755989
• Other study ID #: morphine gel
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 18, 2008
• Last updated: September 18, 2008
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2008
• Source: Banner Health
• Contact: Mary Whitmer, FNP
• Phone: 602-239-6078
• Email: marywhitmer[@]bannerhealth.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Drug:
• morphine topical gel
morphine gel 0.1%, applied every 12 hours to stage 2-3 wound, during their hospital stay
• placebo
topical gel without morphine

Locations

Country	Name	City	State
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Banner Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy with the use of morphine gel applied topically for pain control		1 year	Yes