Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2 participants
INTERVENTIONAL
2013-09-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Sublingual Fentanyl Spray
Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Interventions
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Sublingual Fentanyl Spray
Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Eligibility Criteria
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Inclusion Criteria
* Age 18-65
* Total burn surface area greater than or equal to 5%
* Opioid tolerant
* BMI less than or equal to 35
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Loyola University
OTHER
Responsible Party
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Joseph Holtman
Professor
Principal Investigators
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Joseph R Holtman Jr, MD Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department Anesthesiology Loyola University Medical Center
Locations
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Loyola University Medical Center Burn Unit
Maywood, Illinois, United States
Countries
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Other Identifiers
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205025
Identifier Type: -
Identifier Source: org_study_id
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