Back to resultsSublingual Fentanyl and Procedural Burn Pain
Primary Purpose
Burn Pain
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sublingual Fentanyl Spray
Sponsored by
About this trial
This is an interventional treatment trial for Burn Pain focused on measuring Burn pain, Procedural pain, Sublingual fentanyl, Morphine
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
Sites / Locations
- Loyola University Medical Center Burn Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sublingual Fentanyl Spray
Arm Description
Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Outcomes
Primary Outcome Measures
Pain Relief
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02241486
Brief Title
Sublingual Fentanyl and Procedural Burn Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
No funding source.
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Pain
Keywords
Burn pain, Procedural pain, Sublingual fentanyl, Morphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sublingual Fentanyl Spray
Arm Type
Experimental
Arm Description
Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Intervention Type
Drug
Intervention Name(s)
Sublingual Fentanyl Spray
Intervention Description
Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Primary Outcome Measure Information:
Title
Pain Relief
Description
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.
Time Frame
60 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph R Holtman Jr, MD Ph.D.
Organizational Affiliation
Department Anesthesiology Loyola University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center Burn Unit
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sublingual Fentanyl and Procedural Burn Pain
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