Sublingual Fentanyl and Procedural Burn Pain

Loyola University

Status and phase: Terminated; Phase 3

Conditions: Burn Pain

Treatments: Drug: Sublingual Fentanyl Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT02241486

205025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Sublingual Fentanyl Spray

Experimental group

Description:

Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.

Treatment:

Drug: Sublingual Fentanyl Spray