Clinical Trial: Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Brief Summary: This is a research study on Altitude Illness. From the information collected and studied in this project we hope to learn more about Altitude Illness, including factors that may affect and prevent the development and progression of this condition. We hope to learn if the commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude illness. Possible participants in this study are healthy adults who indicated they would like to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford University researchers hope to enroll about 100 participants.
Detailed Summary:
This study was designed to bring together elements of prior studies and go one step further for definitive data on several points. The trial will employ two pharmaceutical intervention arms, which will compare placebo (the standard of care - information on prevention of altitude sickness) with the widely used NSAID ibuprofen. We will also determine Optic Nerve Sheath Diameter (ONSD) measurements via ultrasound in both the control and interventional arms. We will accomplish these objectives with a prospective, double blinded view of a large population of hikers who are ascending at their own rate in a true hiking environment: The White Mountain Research Station Owen Valley Lab (OVL) and Bancroft Station (BAR).
Primary hypothesis: Ibuprofen 600 mg TID will be superior to placebo in decreasing both the incidence and severity of AMS in high altitude travel.
Sponsor: Stanford University
Current Primary Outcome:
- Acute Mountain Sickness [ Time Frame: 2 days ]Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness
- Acute Mountain Sickness Severity [ Time Frame: 2 days ]Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms
Original Primary Outcome: Acute Mountain Sickness via Lake Louis Score [ Time Frame: 2 days ]
Current Secondary Outcome:
Original Secondary Outcome: Optic Never Sheath Diameter via Occular Ultrasound [ Time Frame: 2 days ]
Information By: Stanford University
Dates:
Date Received: July 27, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017
