Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- incidence of acute mountain sickness
研究概览
简要总结
This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California.
详细描述
The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6 hours prior to ascent is effective for the prevention of AMS, with a number needed to treat of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to acetazolamide, with a NNT of 3 -8, although these two medications have not been directly compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS prophylactic medication and the most commonly used drug for AMS prevention. Although acetazolamide has been given a 1A indication, it has been shown to limit exercise capabilities at high altitude, and rapid ascent has been shown to attenuate its protective effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society Practice Guidelines, in part because it has not directly compared to acetazolamide. It is unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to acetazolamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
visually identical pills
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
- 是
入选标准
- •Age 18-65 healthy non-pregnant volunteer
- •Sea-level dwelling (live at low elevation < 4000 ft)
- •Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
- •Available for full study duration (Friday PM-Sunday AM)
排除标准
- •Age <18 or >65, Pregnant, Live at altitude >4000 ft
- •Slept at altitude > 4000ft within 1 week of study
- •Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
- •Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
- •Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.
研究组 & 干预措施
Ibuprofen
ibuprofen, 600mg, three times a day, through to ascent to high altitude
干预措施: Ibuprofen (Drug)
acetazolamide
acetazolamide, 125mg, two times a day, through to ascent to high altitude
干预措施: Acetazolamide (Drug)
结局指标
主要结局
incidence of acute mountain sickness
时间窗: 2 days
incidence of acute mountain sickness by Lake Louise Questionnaire
次要结局
- severity of acute mountain sickness(2 days)
- oxygen saturation(2 days)
- Groningen Sleep Quality Questionnaire (GSQQ)(2 days)
研究者
Grant S Lipman
Principal Investigator
Stanford University
