Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01522326|
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : September 14, 2016
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 effects of metoclopramide (which has been study-proven to be effective in relieving symptoms of migraine headache) will prove to be more efficacious in relieving symptoms of acute mountain sickness than the standard, previously-studied analgesic medication, ibuprofen.
|Condition or disease||Intervention/treatment||Phase|
|Acute Mountain Sickness High Altitude Headache||Drug: Ibuprofen Drug: Metoclopramide||Not Applicable|
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 setting of a recent increase in altitude. When HAH is associated with nausea, vomiting, fatigue, weakness, dizziness, lightheadedness or poor sleeping, AMS is diagnosed. While benign, AMS is very common, afflicting up to 80 % of travelers who ascend rapidly to 14,000 ft, and can be debilitating. AMS is thought to occur secondary to hypoxia-induced cerebral vasodilation. The antiemetic metoclopramide has been well studied and is commonly administered for treatment of migraine headaches in emergency departments across the U.S. The symptoms of migraine headaches are often similar to those of AMS. The mechanism of metoclopramide‟s beneficial effect in this indication appear to be a result of its antagonism of central and peripheral dopamine receptors,most notably by blocking stimulation of the medullary chemoreceptor trigger zone. No studies have yet evaluated the potential benefits of metoclopramide for the relief of AMS. In contrast, ibuprofen has been well studied and found to be an effective treatment for the relief of symptoms of high altitude headache and AMS.
The study will be a convenience sample of trekkers traveling through the Annapurna Circuit in Nepal during the 3 month time period of March-May, 2012. Subjects will be recruited from visitors to Manang, Nepal staying in local hostels, those visiting the Himalayan Rescue Association clinic in Manang, and those responding to locally posted signage regarding study enrollment.
Eligible patients will be consented and enrolled in the study. Patients will be randomized to receive either Ibuprofen 400mg or Metoclopramide 10mg by mouth. Investigators will be blinded as to which arm of the study the patient is enrolled. Participants will be assessed by Lake Louise Score and Visual Analog Scale for headache and nausea severity immediately prior to ingestion of study medication, and then serially at 30, 60, and 120 minutes following medication ingestion. Standard statistical analysis of the Lake Louise AMS scores and visual analog scales will be used to determine which medication is more effective in treating acute mountain sickness.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Acute Mountain Sickness Treatment: A Double-blind Comparison of Metoclopramide vs. Ibuprofen|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
150 subjects with acute mountain sickness will be randomly assigned to take metoclopramide.
Metoclopramide 10mg tablet. Take one tablet by mouth.
Other Name: Reglan
Active Comparator: Ibuprofen
150 subjects with acute mountain sickness will be randomly assigned to take ibuprofen.
Ibuprofen 400mg tablet. Take one dose by mouth.
- Headache and Nausea Visual Analog Scales [ Time Frame: 120 minutes ]Subjects will complete 100mm visual analog scales of both headache and nausea at time zero, 30, 60, and 120 minutes after taking the study medication. Visual analog scales are a valid assessment of symptom severity for acute mountain sickness.
- Lake Louise Acute Mountain Sickness Score [ Time Frame: 120 minutes ]Subjects will take the Lake Louise Acute Mountains Sickness score before taking the medication and 120 minutes after taking the medication. The Lake Louise Acute Mountain Sickness Score is a standard measure of the severity of acute mountain sickness and is commonly used in studies involving acute mountain sickness.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522326
|Contact: John B Tanner, MD||206-661-1143||JBTANNER@PARTNERS.ORG|
|Manang Clinic of the Himalayan Rescue Association||Recruiting|
|Manang, District of Manang, Nepal, 33500|
|Contact: John B Tanner, MD 206-661-1143 JBTANNER@PARTNERS.ORG|
|Sub-Investigator: John B Tanner, MD|
|Principal Investigator:||Norman S Harris, MD, MFA||Massachusetts General Hospital|