Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
研究概览
简要总结
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"
详细描述
The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
- •only if Emergency Department provider approves
- •a negative pregnancy test is required for participation for women of childbearing age
排除标准
- •If treating provider determines intravenous analgesia is required
- •allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
- •if patient has already been administered an opioid analgesic for their current injury
- •patients on chronic opioids therapy or a history of opioid abuse
- •breastfeeding mothers
- •patients who plan to drive home after their emergency department visit
- •history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)
研究组 & 干预措施
Low-FBT
Subject will receive FBT and placebo at a low dose
干预措施: Fentanyl (Drug)
High-FBT
Subject will receive the high dose regimen of FBT and a high dose placebo
干预措施: Fentanyl (Drug)
Low control
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
干预措施: oxycodone/acetaminophen (Drug)
High control
Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"
干预措施: oxycodone/acetaminophen (Drug)
结局指标
主要结局
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
时间窗: 60 minutes
Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).
次要结局
- Number of Participants Experiencing Any Adverse Events(Full 2 hours of the study period)
- Nausea Level(every 5 minutes for the first 60 minutes)