NCT06310642

Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: CHRISTUS Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• AMS
• Acute Mountain Sickness

Interventions

Type	Name	Description
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.
DRUG	Prochlorperazine 10 mg	Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2024-03-15
• Last updated: 2024-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study