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Ibuprofen vs Acetaminophen for AMS Prevention

NCT02244437 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2016-03-17

No results posted yet for this study

Summary

AMS (acute mountain sickness) affects those who ascend too high (\>2000m) too fast. Acetazolamide is an effective drug for the prevention of AMS where proper acclimatization with gradual ascent may not be an option. AMS presents with headache and other non-specific symptoms such as nausea, tiredness, and dizziness. Because of the side effects of acetazolamide such as a tingling sensation, other drugs have been investigated to see if they will prevent AMS. Ibuprofen has recently been shown to prevent AMS. In this present study the investigators want to see if acetaminophen can also prevent AMS as acetaminophen unlike ibuprofen does not have gastric side effects. Second, because acetaminophen has much less anti-inflammatory component than ibuprofen, it may also provide some insight into the pathophysiology of AMS if acetaminophen were found to be effective in the prevention of AMS.

Conditions

  • Acute Mountain Sickness, Blood Oxygen Saturation, Headache

Interventions

DRUG

Ibuprofen

DRUG

Acetaminophen

Sponsors & Collaborators

  • Mountain Medicine Society of Nepal

    lead OTHER

Principal Investigators

  • Buddha Basnyat, MD · Mountain Medicine Society of Nepal (MMSN), Nepal International Clinic (NIC) and Oxford University Clinical Research Unit (OUCRU), Kathmandu, Nepal

  • Matiram Pun, MBBS/MSc/MA · Mountain Medicine Society of Nepal (MMSN) and Department of Clinical Physiology, Maharajgunj Medical Campus, Institute of Medicine (IOM), Kathmandu, Nepal

  • Nicholas C Kanaan, MD · Department of Surgery, Division of Emergency Medicine, University of Utah, Salt Lake City, UT, USA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Nepal

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02244437 on ClinicalTrials.gov