Skip to content

Altitude Sickness in Climbers and Efficacy of Non-steroidal anti-inflammatory drugs (NSAIDs) Trial

Randomised, double blind placebo controlled trial comparing Ibuprofen 600 mg three times per day versus placebo in the prevention of acute mountain sickness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91790322
Enrollment
350
Registered
2008-09-22
Start date
2008-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High altitude headache (HAH) and acute mountain sickness (AMS) Injury, Occupational Diseases, Poisoning Effects of air pressure and water pressure

Interventions

Ibuprofen 600 mg TID given at least 18 - 24 hours in advance of ascent, versus placebo. Participants will begin the study capsules 18 - 24 hours before they leave from Pheriche (4280 m) or Dingboche (
amounting to three doses before ascent. In the highly unlikely event of an adverse reaction, the participant will be in close proximity to study administrators and the Himalayan Rescue Association aid

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy men or women between the ages of 18 and 65 without any current illness 2. Travelling directly to either Mount Everest Base camp or Kala Patthar 3. Not using any drugs for the prevention of altitude sickness or headache

Exclusion criteria

Exclusion criteria: 1. Younger than 18 years old or are 65 years or older 2. Going to Gokyo, Chukung Ri, or Island Peak before going to Kala Patthar or Everest base camp 3. Have altitude sickness, more than one mild symptom on the Lake Louise Questionnaire (LLQ) (see below), or significantly depressed oxygen saturation (less than 75%) 4. If female, either known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days 5. A known drug allergy to ibuprofen/motrin, naprosyn/naproxen or aspirin 6. Already stayed the night at an altitude of 4500 metres/14,000 feet within the last 9 days 7. Have taken any of the following in the last 2 days: acetazolamide (Diamox®), steroids (dexamethasone/decadron, prednisone), theophylline or diuretics (Lasix®) 8. Have taken any of the following within the last 8 hours: ibuprofen/motrin, naprosyn/naproxen, aspirin or acetaminophen 9. Any serious intracranial abnormalities such as history of brain tumours or pseudotumour cerebri 10. Have any known severe uncontrolled headache syndrome

Design outcomes

Primary

MeasureTime frame
A diagnosis of AMS on the LLQ requires a score of three or greater with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.

Secondary

MeasureTime frame
1. Oxygen saturation has a rough correlation with AMS symptoms, and will be measured with the use of a pulse oximeter, which is validated for use at high altitude (Nonin Onyx, Nonin Medical Products, Minneapolis, MN) 2. HAH incidence and severity will be scored based on a visual analog scale and the headache score identified on the designated LLQ score at a given altitude 3. Measurement of the optic nerve sheath diameter (ONSD) using bedside ultrasound have been shown to correlate with clinical and radiologic signs/symptoms of increased intracranial pressure

Countries

Nepal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026