Skip to main content
OpenTrials
Completed

NCT Number: NCT06310642

Efficacy of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

AMS Acute Mountain Sickness Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency

Corpus Christi, Texas, 78405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate descent from altitude.

Other

Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.

diphenhydramine

Drug

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

Prochlorperazine 10 mg

Drug

Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

CHRISTUS Health

Other

Registry information

Official study title

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

Acronym: PAMS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.