Clinical Trial: Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary: The specific aim of this study is to evaluate if acetazolamide will be superior to ibuprofen 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.
Sponsor: Grant S Lipman

Current Primary Outcome: incidence of acute mountain sickness [ Time Frame: 2 days ]

incidence of acute mountain sickness by Lake Louise Questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • severity of acute mountain sickness [ Time Frame: 2 days ]
    severity of acute mountain sickness by Lake Louise Questionnaire (0-15)
  • oxygen saturation [ Time Frame: 2 days ]
    measurement of oxygen saturation (%) by fingertip pulse oximetry
  • Groningen Sleep Quality Questionnaire (GSQQ) [ Time Frame: 2 days ]
    Groningen Sleep Quality Questionnaire (GSQQ) (0-14)


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: May 11, 2017
Date Started: August 1, 2017
Date Completion: October 1, 2017
Last Updated: May 12, 2017
Last Verified: May 2017