Sublingual Fentanyl and Procedural Burn Pain

Burn Pain Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Cross-over Trial of Sublingual Fentanyl Spray (Subsys) and Oral Morphine for Procedural Wound Care in Adult Patients With Burn Injury Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02241486
• Other study ID #: 205025
• Status: Terminated
• Phase: Phase 3
• First received: November 12, 2013
• Last updated: April 3, 2017
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2017
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Pain
• Burns

Intervention

Drug:
• Sublingual Fentanyl Spray

Locations

Country	Name	City	State
United States	Loyola University Medical Center Burn Unit	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief		60 min
Secondary	Incidence of side effects - nausea, vomiting, pruritis, sedation, respiratory depression		60 min