Overview

Sublingual Fentanyl and Procedural Burn Pain

Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Loyola University
Treatments:
Fentanyl
Morphine
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