Ibuprofen vs Acetaminophen for AMS Prevention

NCT02244437 | Completed Phase 4 DMC

• 1 other identifier: 202/2013
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

altitude, altitude illnesses, headache

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Acute Mountain Sickness (AMS)

  AMS diagnosis will be done using Lake Louise Questionnaire (LLQ) which requires a score of three or greater with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping. LLQ is a self-report symptom questionnaire and it will be assessed among all the study participants upon arrival to the study end point i.e. 5000m altitude (Lobuche) as specified above.

  Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.

Secondary Outcomes (3)

• Blood Oxygen Saturation (SPO2)

  Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.

• Heart Rate (HR)

  Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.

• High Altitude Headache (HAH)

  Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.

Study Arms (2)

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen has been shown to prevent AMS from previous studies.

Drug: Ibuprofen

Acetaminophen

EXPERIMENTAL

Acetaminophen has not been tested yet in AMS prevention.

Drug: Acetaminophen

Interventions

Ibuprofen DRUG

Also known as: 600 mg per oral three times in a day

Ibuprofen

Acetaminophen DRUG

Also known as: 1g per oral three times in a day

Acetaminophen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects between the ages of 18 and 65, male or female, non-Nepali, without AMS or any concurrent illness, and not already taking NSAIDs and acetazolamide or any other drug for the prevention of altitude illness. Subjects will be enrolled by study administrators en route directly to Everest Base Camp or Kala Patthar between the villages of Pheriche/Dingboche and Lobuche.

Sponsors & Collaborators

• Mountain Medicine Society of Nepal: lead

Study Sites (1)

Buddha Basnyat, MD

Kathmandu, Nepal

Location

MeSH Terms

Conditions

Altitude Sickness; Headache

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Buddha Basnyat, MD

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

  PRINCIPAL INVESTIGATOR

• 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

  PRINCIPAL INVESTIGATOR

• Nicholas C Kanaan, MD

  Department of Surgery, Division of Emergency Medicine, University of Utah, Salt Lake City, UT, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 14, 2014
• First Posted: September 19, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

NE (1)