Status:
TERMINATED
Sublingual Fentanyl and Procedural Burn Pain
Lead Sponsor:
Loyola University
Conditions:
Burn Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02241486
Start Date
September 1 2013
End Date
March 1 2015
Last Update
July 28 2017
Active Locations (1)
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1
Loyola University Medical Center Burn Unit
Maywood, Illinois, United States, 60153