Study Stopped
No funding source.
Sublingual Fentanyl and Procedural Burn Pain
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
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 16, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
June 9, 2017
CompletedJuly 28, 2017
June 1, 2017
1 year
November 12, 2013
May 5, 2017
June 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
60 min
Study Arms (1)
Sublingual Fentanyl Spray
EXPERIMENTALExamine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Interventions
Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loyola University Medical Center Burn Unit
Maywood, Illinois, 60153, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This trial was terminated prematurely due to a lack of study funding.
Results Point of Contact
- Title
- Dr. Joseph R. Holtman
- Organization
- Loyola University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph R Holtman Jr, MD Ph.D.
Department Anesthesiology Loyola University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 12, 2013
First Posted
September 16, 2014
Study Start
September 1, 2013
Primary Completion
September 1, 2014
Study Completion
March 1, 2015
Last Updated
July 28, 2017
Results First Posted
June 9, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share