Status:
COMPLETED
Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Acute Mountain Sickness
High Altitude Headache
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to determine the efficacy of metoclopramide in relieving the symptoms of Acute Mountain Sickness (AMS). It is our hypothesis that the combined antiemetic and analgesic ...
Detailed Description
Acute Mountain Sickness (AMS) is a well described disease process that occurs as a result of rapid exposure to high altitude. High altitude headache (HAH) is defined as the presence of headache in the...
Eligibility Criteria
Inclusion
- Presence at Manang recruitment center (at approximately 11,500 ft) during the dates March through May, 2012.
- Recent increase in altitude of \> 1000 ft vertical in last 24 hours
- Presence of headache and at least one other symptom required for diagnosis of acute mountain sickness (including nausea, vomiting, fatigue, weakness, dizziness, lightheadedness or poor sleeping.)
Exclusion
- Age less than 19 years old
- Known allergy or contraindication to either ibuprofen or metoclopramide
- Evidence of severe high altitude illness (e.g. High altitude pulmonary edema (HAPE) as evidenced by dyspnea at rest -- or of High Altitude Cerebral Edema (HACE) as evidenced by altered mental status or ataxia)
- Known or suspected pregnancy
- Use of other analgesic or antiemetic within 8 hours of study enrollment
- History of migraines or other chronic headache disorders
- Inability to provide informed consent
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01522326
Start Date
March 1 2012
End Date
March 30 2017
Last Update
September 2 2020
Active Locations (1)
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1
Manang Clinic of the Himalayan Rescue Association
Manang, District of Manang, Nepal, 33500