Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change in numeric rating scale
研究概览
简要总结
This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo.
The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times:
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Numeric rating scale (1 to 10): Admission
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Numeric rating scale (1 to 10): After the study drug (No ambulation)*
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Numeric rating scale (1 to 10): After the study drug (Ambulation)*
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Ambulation refers to head movements or walking in the room, if applicable.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to emergency department with vertigo symptoms
- •Adult patients (over 18)
- •Agree to participate to study (understanding the study protocol and signing the informed consent form)
排除标准
- •Patients under 18 years
- •Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
- •Patient diagnosed with transient ischemic attack
- •Pregnants
- •Patients taking any analgesics or antihistaminic drugs last 24 hours
- •Documented or declared allergy to dimenhydrinate, piracetam or benzodiazepines
- •Patients who do not agree to participate to the study
研究组 & 干预措施
Piracetam
2 g intravenous piracetam
干预措施: 2 g piracetam intravenous (Drug)
Dimenhydrinate
Dimenhydrinate 100 mg intravenous
干预措施: Administration of 100 mg dimenhydrinate intravenous (Drug)
结局指标
主要结局
Change in numeric rating scale
时间窗: Change from baseline in numeric rating scale at 30th minute
次要结局
未报告次要终点
研究者
Nurettin Özgür Doğan
Assistant Professor
Kocaeli University