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

Banner Health1 site in 1 country100 target enrollmentApril 1, 2009

ConditionsWounds

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wounds
Sponsor: Banner Health
Enrollment: 100
Locations: 1
Primary Endpoint: Safety and efficacy with the use of morphine gel applied topically for pain control
Status: Withdrawn
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2009

End Date

April 1, 2010

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Banner Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated consent form \& HIPAA
•\>/= 18 yo
•Single stage 2-3 wound evaluated by our wound care team
•Alert and oriented (thinking ability clear and intact, physician approval)
•English language proficiency, likely to be able to participate in all scheduled evaluations

Exclusion Criteria

•Allergy to morphine, codeine, or versa base
•pts taking medications for acute condition, other than for the wound pain (can be taking chronic pain meds if current dose stable for past 3 mo)
•Patients with neuropathies
•Patients with respiratory conditions
•Patients that are pregnant