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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pain Relief
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sublingual Fentanyl Spray (Drug)
结局指标
主要结局
Pain Relief
时间窗: 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.
次要结局
未报告次要终点
研究者
Joseph Holtman
Professor
Loyola University