Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness (PAMS)

March 7, 2024 updated by: Peter Richman, MD, CHRISTUS Health

A Prospective Single-Blinded Randomized Field-Based Trial to Evaluate the Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a prospective, single-blinded, field-based interventional trial involving consenting, healthy subjects aged >17 years. The study was conducted on the big Island of Hawaii, at sea level and at the summit of Mauna Kea volcano. Following randomization, subjects received either placebo or 10mg prochlorperazine, then immediately drove for 2 hours from sea level to the volcano summit (4205m). Participants spent 240 min at the summit, and they recorded their symptoms. AMS was defined by the previously validated Lake Louise Acute Mountain Sickness Score (LLAMS). Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Corpus Christi, Texas, United States, 78405
        • CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria - Healthy subjects aged >17 years

Exclusion criteria-subject meets any of the following:

  • Known allergy or contraindication to the study drug.
  • Known or suspected pregnancy.
  • Use of another analgesic or antiemetic within 8 hours of enrollment.
  • History of chronic headaches.
  • Inability to provide informed consent.
  • Use of central nervous system depressants, including alcohol, opiates, and/or barbiturates, within 24 hours of the study start time.
  • History of severe depression.
  • History of dementia.
  • Prior ascent and stay at 2500m for duration over 6 weeks within 30 days prior.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prochlorperazine 10 mg
Subjects received 10 mg Prochlorperazine one time.
Other: Immediate descent from altitude.
Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.
Drug: Diphenhydramine
Diphenhydramine was available to counteract any potential extrapyramidal side effects of the study drug. The use of Diphenhydramine for this purpose is well established.
Other Names:
  • Benadryl
Drug: Prochlorperazine 10 mg
Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent
Placebo Comparator: Placebo
Subjects received Placebo one time.
Other: Immediate descent from altitude.
Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.
Drug: Diphenhydramine
Diphenhydramine was available to counteract any potential extrapyramidal side effects of the study drug. The use of Diphenhydramine for this purpose is well established.
Other Names:
  • Benadryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups
Time Frame: LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)

The study drug was administered at sea level (time 0). Immediately thereafter, participants drove 120 minutes to the summit. They spent an additional 240 minutes at the summit. Symptoms were recorded 360 minutes after drug administration while still at the summit. The primary outcome was the difference in mean LLAMS scores between the prochlorperazine and placebo groups (t-tests).

Previously validated Lake Louise Acute Mountain Sickness Score (LLAMS) were utilized. Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.
LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups
Time Frame: LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)
The study drug was administered at sea level (time 0). Immediately thereafter, participants drove 120 minutes to the summit. They spent an additional 240 minutes at the summit. Symptoms were recorded 360 minutes after drug administration while still at the summit. Acute mountain sickness defined as having a headache score of at least one point, and a total score of at least three points. The prochlorperazine and placebo groups were compared for incidence of acute mountain sickness (chi-square)
LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHRISTUS Health

Investigators

  • Principal Investigator: Peter Richman, MD, CHRISTUS Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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