Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
- Conditions
- Acute Mountain SicknessAMS
- Interventions
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
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. Placebo Immediate descent from altitude. Subjects received Placebo one time. Prochlorperazine 10 mg Prochlorperazine 10 mg Subjects received 10 mg Prochlorperazine 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 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 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 score of at least three points. The prochlorperazine and placebo groups were compared for incidence of acute mountain sickness (chi-square)
Trial Locations
- Locations (1)
CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency
🇺🇸Corpus Christi, Texas, United States