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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Massachusetts General Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
N. Stuart Harris MD MFA, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01522326
First received: January 27, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Headache and Nausea Visual Analog Scales [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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: December 2012
Estimated Primary Completion Date: June 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522326

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

Locations
Nepal
Manang Clinic of the Himalayan Rescue Association Not yet 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:
Hultgren HN. High Altitude Pulmonary Edema. High Altitude Medicine. Stanford, CA: Hultgren Publications; 1997.

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
Study First Received: January 27, 2012
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board
Nepal: Health Research Council

Keywords provided by 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
Respiration Disorders
Respiratory Tract Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Metoclopramide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 20, 2014