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