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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency
Corpus Christi, Texas, United States
Start Date
May 20, 2021
Primary Completion Date
March 13, 2023
Completion Date
March 13, 2023
Last Updated
May 28, 2024
30
ACTUAL participants
Immediate descent from altitude.
OTHER
Diphenhydramine
DRUG
Prochlorperazine 10 mg
DRUG
Lead Sponsor
CHRISTUS Health
NCT03354416
NCT07021638
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