Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Conditions
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Acute Mountain Sickness

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Acetazolamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized double blind controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br>ibuprofen, 600mg, three times a day, through to ascent to high altitude | Drug: Ibuprofen<br>* non-steroidal anti-inflammatory drug<br>* Other names: Motrin;|
| Active Comparator: acetazolamide<br>acetazolamide, 125mg, two times a day, through to ascent to high altitude | Drug: Acetazolamide<br>* a diuretic<br>* Other names: diamox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute mountain sickness | incidence of acute mountain sickness by Lake Louise Questionnaire | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of acute mountain sickness | severity of acute mountain sickness by Lake Louise Questionnaire (0-15) | 2 days | 
| oxygen saturation | measurement of oxygen saturation (%) by fingertip pulse oximetry | 2 days | 
| Groningen Sleep Quality Questionnaire (GSQQ) | Groningen Sleep Quality Questionnaire (GSQQ) (0-14) | 2 days |