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

Acute Mountain Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522326
• Other study ID #: 2010P002837
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: March 30, 2017

Study information

• Verified date: September 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 30, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• Headache
• High Altitude Headache

Intervention

Drug:
• Ibuprofen
Ibuprofen 400mg tablet. Take one dose by mouth.
• Metoclopramide
Metoclopramide 10mg tablet. Take one tablet by mouth.

Locations

Country	Name	City	State
Nepal	Manang Clinic of the Himalayan Rescue Association	Manang	District Of Manang

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

Nepal, 

References & Publications (20)

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Friedman BW, Corbo J, Lipton RB, Bijur PE, Esses D, Solorzano C, Gallagher EJ. A trial of metoclopramide vs sumatriptan for the emergency department treatment of migraines. Neurology. 2005 Feb 8;64(3):463-8. — View Citation

Gertsch JH, Lipman GS, Holck PS, Merritt A, Mulcahy A, Fisher RS, Basnyat B, Allison E, Hanzelka K, Hazan A, Meyers Z, Odegaard J, Pook B, Thompson M, Slomovic B, Wahlberg H, Wilshaw V, Weiss EA, Zafren K. Prospective, double-blind, randomized, placebo-controlled comparison of acetazolamide versus ibuprofen for prophylaxis against high altitude headache: the Headache Evaluation at Altitude Trial (HEAT). Wilderness Environ Med. 2010 Sep;21(3):236-43. doi: 10.1016/j.wem.2010.06.009. Epub 2010 Jun 16. — View Citation

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Gilbert DL. The first documented report of mountain sickness: the China or Headache Mountain story. Respir Physiol. 1983 Jun;52(3):315-26. — View Citation

Griffith JD, Mycyk MB, Kyriacou DN. Metoclopramide versus hydromorphone for the emergency department treatment of migraine headache. J Pain. 2008 Jan;9(1):88-94. Epub 2007 Nov 5. — View Citation

Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55. — View Citation

Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. Review. — View Citation

Harris NS, Wenzel RP, Thomas SH. High altitude headache: efficacy of acetaminophen vs. ibuprofen in a randomized, controlled trial. J Emerg Med. 2003 May;24(4):383-7. — View Citation

Hultgren HN. High Altitude Pulmonary Edema. High Altitude Medicine. Stanford, CA: Hultgren Publications; 1997.

Kayser B, Aliverti A, Pellegrino R, Dellaca R, Quaranta M, Pompilio P, Miserocchi G, Cogo A. Comparison of a visual analogue scale and Lake Louise symptom scores for acute mountain sickness. High Alt Med Biol. 2010 Spring;11(1):69-72. doi: 10.1089/ham.2009.1046. — View Citation

Kirthi V, Derry S, Moore RA, McQuay HJ. Aspirin with or without an antiemetic for acute migraine headaches in adults. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008041. doi: 10.1002/14651858.CD008041.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;(4):CD008041. — View Citation

Maggiorini M, Bühler B, Walter M, Oelz O. Prevalence of acute mountain sickness in the Swiss Alps. BMJ. 1990 Oct 13;301(6756):853-5. — View Citation

Montgomery AB, Mills J, Luce JM. Incidence of acute mountain sickness at intermediate altitude. JAMA. 1989 Feb 3;261(5):732-4. — View Citation

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.

Schneider M, Bernasch D, Weymann J, Holle R, Bartsch P. Acute mountain sickness: influence of susceptibility, preexposure, and ascent rate. Med Sci Sports Exerc. 2002 Dec;34(12):1886-91. — View Citation

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.

Zell SC, Goodman PH. Acetazolamide and dexamethasone in the prevention of acute mountain sickness. West J Med. 1988 May;148(5):541-5. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache and Nausea Visual Analog Scales	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.	120 minutes
Secondary	Lake Louise Acute Mountain Sickness Score	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.	120 minutes