Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

Acute Mountain Sickness Clinical Trial

— PAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06310642
• Other study ID #: 2020-217
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2021
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2024
• Source: CHRISTUS Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• AMS

Intervention

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.
• Prochlorperazine 10 mg
Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent

Locations

Country	Name	City	State
United States	CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency	Corpus Christi	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CHRISTUS Health

Country where clinical trial is conducted

United States, 

References & Publications (8)

Irons HR, Salas RN, Bhai SF, Gregorie WD, Harris NS. Prospective Double-Blinded Randomized Field-Based Clinical Trial of Metoclopramide and Ibuprofen for the Treatment of High Altitude Headache and Acute Mountain Sickness. Wilderness Environ Med. 2020 Mar;31(1):38-43. doi: 10.1016/j.wem.2019.11.005. Epub 2020 Feb 11. — View Citation

Kanaan NC, Peterson AL, Pun M, Holck PS, Starling J, Basyal B, Freeman TF, Gehner JR, Keyes L, Levin DR, O'Leary CJ, Stuart KE, Thapa GB, Tiwari A, Velgersdyk JL, Zafren K, Basnyat B. Prophylactic Acetaminophen or Ibuprofen Results in Equivalent Acute Mountain Sickness Incidence at High Altitude: A Prospective Randomized Trial. Wilderness Environ Med. 2017 Jun;28(2):72-78. doi: 10.1016/j.wem.2016.12.011. Epub 2017 May 4. Erratum In: Wilderness Environ Med. 2017 Sep;28(3):281. — View Citation

Klocke DL, Decker WW, Stepanek J. Altitude-related illnesses. Mayo Clin Proc. 1998 Oct;73(10):988-92; quiz 992-3. doi: 10.4065/73.10.988. — View Citation

Lu H, Wang R, Xiong J, Xie H, Kayser B, Jia ZP. In search for better pharmacological prophylaxis for acute mountain sickness: looking in other directions. Acta Physiol (Oxf). 2015 May;214(1):51-62. doi: 10.1111/apha.12490. Epub 2015 Mar 28. — View Citation

Luks AM, Auerbach PS, Freer L, Grissom CK, Keyes LE, McIntosh SE, Rodway GW, Schoene RB, Zafren K, Hackett PH. Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Acute Altitude Illness: 2019 Update. Wilderness Environ Med. 2019 Dec;30(4S):S3-S18. doi: 10.1016/j.wem.2019.04.006. Epub 2019 Jun 24. — View Citation

Netzer N, Strohl K, Faulhaber M, Gatterer H, Burtscher M. Hypoxia-related altitude illnesses. J Travel Med. 2013 Jul-Aug;20(4):247-55. doi: 10.1111/jtm.12017. Epub 2013 Mar 11. — View Citation

Olson LG, Hensley MJ, Saunders NA. The effects of combined morphine and prochlorperazine on ventilatory control in humans. Am Rev Respir Dis. 1986 Apr;133(4):558-61. doi: 10.1164/arrd.1986.133.4.558. — View Citation

Smedley T, Grocott MP. Acute high-altitude illness: a clinically orientated review. Br J Pain. 2013 May;7(2):85-94. doi: 10.1177/2049463713489539. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups	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.	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)
Secondary	Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups	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)	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)