Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

Altitude Sickness Clinical Trial

Official title:

Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171794
• Other study ID #: SU-12012009-4443
• Status: Completed
• Phase: Phase 3
• Start date: July 2010
• Est. completion date: August 2010

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy Male or female volunteer

2. Age 18-65

3. Sea-level dwelling

4. Non pregnant

5. Have not been to high altitude in the past week

6. Can arrange for their own transportation to WMRS by friday evening the weekend of their study enrollment and are available the duration of the weekend of their study enrollment

Exclusion Criteria:

1. Age <18 or >65

2. Live at altitude > Sea Level +/- 1000'

3. Pregnant

4. Taking NSAIDs, Acetazolamide, or Corticosteroids

5. Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past

6. Traveled or planning to travel to high altitude in the week prior to their enrollment.

7. Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri, ventricular shunts, loss of an eye, Asthma, HACE or HAPE.

8. Cannot arrange for their own transportation to WMRS or are unavailable for the duration of the weekend of their study enrollment

Related Conditions & MeSH terms

• Altitude Sickness

Intervention

Drug:
• Ibuprofen
3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
• Placebo
identical number of visually identical tasteless pills as ibuprofen arm

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lipman GS, Kanaan NC, Holck PS, Constance BB, Gertsch JH; PAINS Group. Ibuprofen prevents altitude illness: a randomized controlled trial for prevention of altitude illness with nonsteroidal anti-inflammatories. Ann Emerg Med. 2012 Jun;59(6):484-90. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Mountain Sickness	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	2 days
Primary	Acute Mountain Sickness Severity	Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms	2 days