Status:
COMPLETED
Ibuprofen vs Acetaminophen for AMS Prevention
Lead Sponsor:
Mountain Medicine Society of Nepal
Conditions:
Acute Mountain Sickness, Blood Oxygen Saturation, Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
AMS (acute mountain sickness) affects those who ascend too high (\>2000m) too fast. Acetazolamide is an effective drug for the prevention of AMS where proper acclimatization with gradual ascent may no...
Detailed Description
Acute mountain sickness (AMS) is a well-known disorder in sojourners to high altitude (\>2000m) characterized by headache, nausea and tiredness, akin to hangover-like symptoms. The Lake Louise criteri...
Eligibility Criteria
Inclusion
- Healthy subjects between the ages of 18 and 65, male or female, non-Nepali, without AMS or any concurrent illness, and not already taking NSAIDs and acetazolamide or any other drug for the prevention of altitude illness. Subjects will be enrolled by study administrators en route directly to Everest Base Camp or Kala Patthar between the villages of Pheriche/Dingboche and Lobuche.
Exclusion
- Individuals not meeting inclusion criteria, including mild AMS (more than one mild symptom on the Lake Louise Questionnaire) or significantly depressed oxygen saturation (\<75%); females known to be pregnant, cannot exclude the possibility of being pregnant, or have missed menses by over 7 days; individuals who have spent 24 hours at an altitude of 4500 meters/14,000 feet within the last 9 days; anyone known to have taken any of the following in the last 2 days: acetazolamide (Diamox®), steroids (dexamethasone, prednisone), theophylline, or diuretics (Lasix®); individuals who have a known intracranial space occupying lesion or a history of elevated intracranial pressure, (i.e. tumors, hydrocephalus, etc).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT02244437
Start Date
October 1 2014
End Date
December 1 2015
Last Update
March 17 2016
Active Locations (1)
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1
Buddha Basnyat, MD
Kathmandu, Nepal