NCT01827293已完成3 期
Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial
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
- 210
- 试验地点
- 1
- 主要终点
- Mean change in vertigo intensity.
研究概览
简要总结
This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged 18 years or older
- •Background history of positional vertigo
排除标准
- •Unable to provide informed consent
- •Pregnant or possibly pregnant
- •Known allergy to study medications
- •Use of antiemetic agents in the previous 24 hours
- •Evidence of drug-induced vertigo or orthostatic hypotension
- •Central pathologies/central origin for vertigo
研究组 & 干预措施
Promethazine
Active Comparator
IV promethazine (25 mg)
干预措施: Promethazine (Drug)
Promethazine
Active Comparator
IV promethazine (25 mg)
干预措施: Lorazepam (Drug)
lorazepam
Active Comparator
IV lorazepam (2 mg)
干预措施: Promethazine (Drug)
lorazepam
Active Comparator
IV lorazepam (2 mg)
干预措施: Lorazepam (Drug)
结局指标
主要结局
Mean change in vertigo intensity.
时间窗: At 2 hours after intervention.
The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications.
次要结局
- Efficacy and Safety outcome measures (nausea change-second dose-adverse events).(At 2-8 hours after intervention.)
研究者
Shadi Asadollahi
Research Assistant
Shahid Beheshti University of Medical Sciences
研究点 (1)
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