Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

Phase 4

Completed

• Conditions: Acute Mountain Sickness; AMS
• Interventions: Other: Immediate descent from altitude.; Drug: Diphenhydramine; Drug: Prochlorperazine 10 mg

• Registration Number: NCT06310642
• Lead Sponsor: CHRISTUS Health

Brief 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 s...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-20
• Primary Completion: 2023-03-13
• Study Completion: 2023-03-13
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prochlorperazine 10 mg	Immediate descent from altitude.	Subjects received 10 mg Prochlorperazine one time.
Prochlorperazine 10 mg	Diphenhydramine	Subjects received 10 mg Prochlorperazine one time.
Prochlorperazine 10 mg	Prochlorperazine 10 mg	Subjects received 10 mg Prochlorperazine one time.
Placebo	Immediate descent from altitude.	Subjects received Placebo one time.
Placebo	Diphenhydramine	Subjects received Placebo one time.

Primary Outcome Measures

Name	Time	Method
Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups	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 pl...

Secondary Outcome Measures

Name	Time	Method
Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups	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 s...

Trial Locations

Locations (1)

CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency; 🇺🇸 Corpus Christi, Texas, United States