A Prospective Single-Blinded Randomized Field-Based Trial to Evaluate the Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups
研究概览
简要总结
A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score.
详细描述
This was a prospective, single-blinded, field-based interventional trial involving consenting, healthy subjects aged >17 years. The study was conducted on the big Island of Hawaii, at sea level and at the summit of Mauna Kea volcano. Following randomization, subjects received either placebo or 10mg prochlorperazine, then immediately drove for 2 hours from sea level to the volcano summit (4205m). Participants spent 240 min at the summit, and they recorded their symptoms. AMS was defined by the previously validated Lake Louise Acute Mountain Sickness Score (LLAMS). Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.
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 (Participant)
盲法说明
Patients were blinded in this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Prochlorperazine 10 mg
Subjects received 10 mg Prochlorperazine one time.
干预措施: Immediate descent from altitude. (Other)
Prochlorperazine 10 mg
Subjects received 10 mg Prochlorperazine one time.
干预措施: Diphenhydramine (Drug)
Prochlorperazine 10 mg
Subjects received 10 mg Prochlorperazine one time.
干预措施: Prochlorperazine 10 mg (Drug)
Placebo
Subjects received Placebo one time.
干预措施: Immediate descent from altitude. (Other)
Placebo
Subjects received Placebo one time.
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups
时间窗: LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)
The study drug was administered at sea level (time 0). Immediately thereafter, participants drove 120 minutes to the summit. They spent an additional 240 minutes at the summit. Symptoms were recorded 360 minutes after drug administration while still at the summit. The primary outcome was the difference in mean LLAMS scores between the prochlorperazine and placebo groups (t-tests). Previously validated Lake Louise Acute Mountain Sickness Score (LLAMS) were utilized. Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.
次要结局
- Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups(LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit))
研究者
Peter Richman, MD
Professor and Research Director, Department of Emergency Medicine
CHRISTUS Health