We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness

This study is currently recruiting participants.
Verified September 2016 by N. Stuart Harris MD MFA, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522326
First Posted: January 31, 2012
Last Update Posted: September 14, 2016
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.
Information provided by (Responsible Party):
N. Stuart Harris MD MFA, Massachusetts General Hospital
  Purpose

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 Intervention
Acute Mountain Sickness High Altitude Headache Drug: Ibuprofen Drug: Metoclopramide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Acute Mountain Sickness Treatment: A Double-blind Comparison of Metoclopramide vs. Ibuprofen

Resource links provided by NLM:


Further study details as provided by N. Stuart Harris MD MFA, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metoclopramide
150 subjects with acute mountain sickness will be randomly assigned to take metoclopramide.
Drug: 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.
Drug: Ibuprofen
Ibuprofen 400mg tablet. Take one dose by mouth.
Other Names:
  • Advil
  • Motrin

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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522326


Contacts
Contact: John B Tanner, MD 206-661-1143 JBTANNER@PARTNERS.ORG

Locations
Nepal
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         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Norman S Harris, MD, MFA Massachusetts General Hospital
  More Information

Publications:
Roach RC, Bartsch P, Hackett PH, Oelz O. The Lake Louise acute mountain sickness scoring system. Hypoxia and Molecular Medicine, J.R. Sutton, C. S. Huston, and G. Coates eds. Burlinton, VT, USA: Queen City Printers; 1993.
Hultgren HN. High Altitude Pulmonary Edema. High Altitude Medicine. Stanford, CA: Hultgren Publications; 1997.
The Lake Louise Consensus on the Definition and Quantification of Altitude Illness. In: Sutton J, Coates G, Houston C, eds. Hypoxia and Molecular Medicine. Burlington, VT: Queen City Printers; 1993.

Responsible Party: N. Stuart Harris MD MFA, Director, MGH Wilderness Medicine Fellowship; Chief, Division of Wilderness Medicine, Department of Emergency Medicine, Massachusetts General Hospital; Assistant Professor of Surgery, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01522326     History of Changes
Other Study ID Numbers: 2010P002837
First Submitted: January 27, 2012
First Posted: January 31, 2012
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by N. Stuart Harris MD MFA, Massachusetts General Hospital:
Acute Mountain Sickness
High Altitude Headache
Lake Louise AMS Score
Visual Analog Scale
Ibuprofen
Metoclopramide
Nepal

Additional relevant MeSH terms:
Altitude Sickness
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Ibuprofen
Metoclopramide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents