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

Sponsor:	Banner Health
Information provided by:	Banner Health
ClinicalTrials.gov Identifier:	NCT00755989

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Placebo Comparator group to receive topical gel without morphine	Drug: placebo topical gel without morphine
2: Experimental 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

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
Phoenix, Arizona, United States, 85006

Sponsors and Collaborators

Banner Health

Investigators

Principal Investigator:

Mary Whitmer, MSN,FNP, APRN BC-PCM

Banner Health

More Information

No publications provided

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

Additional relevant MeSH terms:

Morphine
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010