Sublingual Fentanyl and Procedural Burn Pain

Stopped early · Phase 3

Conditions studied: Burn Pain

In brief

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.

Key facts

Study ID

NCT02241486

Run by

Loyola University

People needed

2

Starts

2013-09-01

Expected to finish

2015-03-01

Last updated by the study team

2017-07-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Loyola University Medical Center Burn Unit — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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