A Randomized, Double-blind, Placebo-controlled, Cross-over Trial of Sublingual Fentanyl Spray (Subsys) and Oral Morphine for Procedural Wound Care in Adult Patients With Burn Injury Pain
Overview
- Phase
- Phase 3
- Intervention
- Sublingual Fentanyl Spray
- Conditions
- Burn Pain
- Sponsor
- Loyola University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Pain Relief
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Detailed Description
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.
Investigators
Joseph Holtman
Professor
Loyola University
Eligibility Criteria
Inclusion Criteria
- •Subject capable of giving consent
- •Age 18-65
- •Total burn surface area greater than or equal to 5%
- •Opioid tolerant
- •BMI less than or equal to 35
Exclusion Criteria
- •Subjects with cognitive or psychiatric impairment that would preclude study participation or compliance with protocol
- •Allergy to fentanyl, morphine, naloxone
- •Pregnancy, intent to become pregnant or lactating
- •Evidence of burn injury to oral mucosa
- •Active illicit drug use or illicit drug abuse history
Arms & Interventions
Sublingual Fentanyl Spray
Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Intervention: Sublingual Fentanyl Spray
Outcomes
Primary Outcomes
Pain Relief
Time Frame: 60 min
Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.