NCT01939314已完成3 期
A Prospective, Randomized, Double-Blind Study Comparing the Efficacy of Sphenopalatine Nerve Block by Localized Mucosal Application of an Anesthetic vs Placebo for the Emergency Department Management
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.
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
- Triple (Participant, Care Provider, Investigator)
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
- •are 18 - 65 years of age
- •present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
- •have a normal neurological exams
排除标准
- •are less than 18 years old or greater than 65
- •have any focal neurological dysfunction signs or symptoms
- •have a posterior/occipital/cervicogenic source predominance of headache
- •are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
- •have self treated with pain medication or anti-emetic 4 hours prior to arrival
- •have a history of peripheral vascular disease, cancer, or HIV infection
- •are known to be pregnant
研究组 & 干预措施
Bupivacaine
Active Comparator
Bupivicaine .03ml to each nare
干预措施: Bupivacaine (Drug)
Normal Saline
Placebo Comparator
normal saline .03 ml to each nare
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
时间窗: 15 minutes from dose
次要结局
- Categorical Pain Relief(15 minutes from dose)
- Headache Free at 24 Hours(24 hours)
研究者
Jason Schaffer
Primary Investigator
Indiana University
研究点 (1)
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