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

Completed

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

• Registration Number: ISRCTN91790322
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)<br>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<br>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