NCT05288348已完成3 期
DSUVIA Early Evaluation of PAIN (DEEP) Trial
Frank Guyette1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年8月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Verbally Administered Numeric Rating Scale (VNRS)
研究概览
简要总结
Randomized, interventional trial of Emergency Department (ED) administration of DSUVIA (sufentanil) versus standard care pain management comparing pain treatment outcomes in injured patients with moderate to severe pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma activation (Level I, II or III)
- •Age 18-70 years inclusive
- •Need for pain treatment based upon NRS (0-100) clinical pain measurement ≥ 50
- •Estimated time in Emergency Department > 30 minutes following informed consent
排除标准
- •Advanced airway management prior to 1st dose administration
- •Known allergy to opioids
- •Known prisoner
- •Known pregnancy
- •ED pain medication contraindicated
- •Significant respiratory depression
- •Known or suspected gastrointestinal obstruction, including paralytic ileus
研究组 & 干预措施
DSUVIA (sufentanil)
Experimental
Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator
干预措施: Sufentanil 30 MCG Sublingual Tablet (Drug)
Standard Care
Active Comparator
Subjects will receive standard care pain management
干预措施: standard care pain treatment (Drug)
结局指标
主要结局
Verbally Administered Numeric Rating Scale (VNRS)
时间窗: 30 minutes after administration
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
次要结局
- Verbally Administered Numeric Rating Scale (VNRS)(Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first)
- Patient Global Assessment (PGA) of Pain Control(every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration))
- Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min(every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration))
- Number of Participants Who Needed Rescue Narcotic Doses(at 30 minutes following administration and during ED stay (up to 120 minutes))
- Patient Cognitive Function as Assessed by Six Item Screener (SIS)(at 30 minutes following administration)
- Healthcare Professional Global Assessment (HPGA) of Method of Pain Control(at 30 minutes following administration)
- Number of Participants With Hypoxia Needing Supplemental Oxygen(from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes))
- Number of Participants With Hypotension(from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes))
- Number of Participants With Nausea(from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes))
- Number of Participants With Vomiting(from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes))
- Number of Participants With Headache(from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes))
- Number of Participants With Dizziness Requiring Treatment(from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes))
- Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min(Time to a 10 point reduction in VNRS following administration of study drug. Participants were followed to 120 min or discharge in 30 min intervals)
- Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management(From drug administration up to 120 min following administration)
- Richmond Agitation-Sedation Scale (RASS)(Assessed at 30 minutes after administration)
- Richmond Agitation-Sedation Scale (RASS) @ 60 Min(RASS @ 60 min)
- Richmond Agitation-Sedation Scale (RASS) @ 90 Min(RASS @ 90 minutes)
- Richmond Agitation-Sedation Scale (RASS) @ 120 Min(RASS @ 120 min)
研究者
Frank Guyette
Professor
University of Pittsburgh
研究点 (1)
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