Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness (PAMS)

CHRISTUS Health

Status and phase: Completed; Phase 4

Conditions: AMS; Acute Mountain Sickness

Treatments: Drug: Prochlorperazine 10 mg; Other: Immediate descent from altitude.; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other

Identifiers

NCT06310642

2020-217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Prochlorperazine 10 mg

Experimental group

Description:

Subjects received 10 mg Prochlorperazine one time.

Treatment:

Drug: Diphenhydramine

Other: Immediate descent from altitude.

Drug: Prochlorperazine 10 mg

Placebo

Placebo Comparator group

Description:

Subjects received Placebo one time.

Treatment:

Drug: Diphenhydramine

Other: Immediate descent from altitude.