Sublingual Fentanyl and Procedural Burn Pain
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/5/2017 |
| Start Date: | September 2013 |
| End Date: | March 2015 |
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
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.
(Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn
injury.
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.
(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.
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
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