Sublingual Fentanyl and Procedural Burn Pain

Phase 3

Terminated

• Conditions: Burn Pain
• Interventions: Drug: Sublingual Fentanyl Spray

• Registration Number: NCT02241486
• Lead Sponsor: Loyola University

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 compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-12
• Primary Completion: 2014-09
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Study Completion: 2015-03
• Results First Submitted: 2017-05-05
• Results First Submitted QC: 2017-05-05
• Status Verified: 2017-06
• Results First Posted: 2017-06-09
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sublingual Fentanyl Spray	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.

Primary Outcome Measures

Name	Time	Method
Pain Relief	60 min	Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Trial Locations

Locations (1)

Loyola University Medical Center Burn Unit; 🇺🇸 Maywood, Illinois, United States