Phase 3
Completed N=89
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Altitude Sickness
Source: ClinicalTrials.gov NCT01171794 ↗
Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Acute Mountain Sickness — 19; 26 Participants
◆ Published Evidence
Established
92citations · ~7 / year
Ibuprofen prevents altitude illness: a randomized controlled trial for prevention of altitude illness with nonsteroidal anti-inflammatories.
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.
Linked Publications
-
Ibuprofen prevents altitude illness: a randomized controlled trial for prevention of altitude illness with nonsteroidal anti-inflammatories.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Mountain Sickness |
19; 26 | — |
| PRIMARY Acute Mountain Sickness Severity |
3.2; 4.4 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy Male or female volunteer
- Age 18-65
- Sea-level dwelling
- Non pregnant
- Have not been to high altitude in the past week
- 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
- Age 65
- Live at altitude > Sea Level +/- 1000'
- Pregnant
- Taking NSAIDs, Acetazolamide, or Corticosteroids
- Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past
- Traveled or planning to travel to high altitude in the week prior to their enrollment.
- Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri, ventricular shunts, loss of an eye, Asthma, HACE or HAPE.
- Cannot arrange for their own transportation to WMRS or are unavailable for the duration of the weekend of their study enrollment
Data sourced from ClinicalTrials.gov (NCT01171794) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.