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

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Brief Title

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

Official Title

Acute Mountain Sickness Treatment: A Double-blind Comparison of Metoclopramide vs. Ibuprofen

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 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.
    

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.
    


Study Type

Interventional


Primary Outcome

Headache and Nausea Visual Analog Scales

Secondary Outcome

 Lake Louise Acute Mountain Sickness Score

Condition

Acute Mountain Sickness

Intervention

Ibuprofen

Study Arms / Comparison Groups

 Metoclopramide
Description:  150 subjects with acute mountain sickness will be randomly assigned to take metoclopramide.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

300

Start Date

March 2012

Completion Date

March 2017

Primary Completion Date

March 2017

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Norman S Harris, MD, MFA, 206-661-1143, [email protected]

Location Countries

Nepal

Location Countries

Nepal

Administrative Informations


NCT ID

NCT01522326

Organization ID

2010P002837


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

Norman S Harris, MD, MFA, Principal Investigator, Massachusetts General Hospital


Verification Date

September 2016