Inhaled Isopropyl Alcohol Versus Placebo to Manage Nausea at Electronic Dance Music Festivals

NCT04307550 | Completed

• 1 other identifier: REB20-0288
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 9

Brief Summary

BACKGROUND Studies have shown that isopropyl alcohol inhalation is effective for the relief of nausea in the emergency department. A 2016 randomized controlled trial found that nasally inhaled isopropyl alcohol achieved better nausea relief compared to placebo during a 10-minute period. In 2018, another randomized controlled trial showed that nasally inhaled isopropyl alcohol with or without oral ondansetron provided greater relief for nausea than oral ondansetron alone. QUESTION In electronic dance music festival attendees, who present with nausea to the medical team, how does inhaled isopropyl alcohol compare with inhaled sterile saline (placebo) for self-reported nausea 10-minutes post-intervention? METHODS Canadian electronic dance music festival attendees who present with nausea to the medical team, will be recruited until sample size reaches at least 70. Inclusion criteria will be festival attendees aged 18+ with a complaint of nausea. Exclusion criteria will include known allergy to isopropyl alcohol, inability to inhale through the nares, inability to report level of nausea, or already have taken an anti-nauseant. After obtaining consent, participants will be randomized into two study arms. Arm 1 will nasally inhale an isopropyl alcohol pad with 10 deep inhalations (intervention). Arm 2 will nasally inhale a sterile saline pad with 10 deep inhalations (placebo). The pad must be within 2cm from the nares to ensure delivery. According to a study in 2002, isopropyl alcohol pad inhalation, dosed at 3 inhalations every 5 minutes for 3 doses, was not significantly different than standard treatment for relief of nausea. 10 inhalations exceeds the 9-dose total reported in the paper, and a one-time bolus dose of 10 inhalations, for the population and festival context, is more feasible in terms of patient compliance and patient flow. After randomization, participants will rate their nausea on a numeric response scale (0 to 10, where 0 is no nausea and 10 is "worst nausea imaginable"). 10-minutes post-inhalation (isopropyl alcohol or placebo), participants will be asked to rate their nausea again. The primary outcome is self-reported nausea scores 10-minutes post-intervention. The secondary outcome is the presence or absence of any vomiting spells 10-minutes post-intervention, as well as the presence or absence of rescue-medication needed 10-minutes post-intervention.

Conditions

Nausea

Outcome Measures

Primary Outcomes (1)

• Self-reported nausea scores

  Nausea rated on an 11-point scale (0 = "no nausea", 10 = "worst nausea imaginable")

  10-minutes post-intervention

Secondary Outcomes (2)

• Presence of vomiting

  10-minutes post-intervention

• Use of rescue-medication (i.e. oral/intravenous anti-nauseant)

  10-minutes post-intervention

Study Arms (2)

Isopropyl Alcohol

EXPERIMENTAL

10 inhalations of an isopropyl alcohol pad held within 2cm from the nares

Drug: Isopropyl alcohol

Sterile Saline

PLACEBO COMPARATOR

10 inhalations of a sterile saline pad held within 2cm from the nares

Other: Placebo

Interventions

Isopropyl alcohol DRUG

10 inhalations of an isopropyl alcohol pad

Also known as: Isopropyl alcohol pad

Isopropyl Alcohol

Placebo OTHER

10 inhalations of a sterile saline pad

Also known as: Sterile saline pad

Sterile Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Festival attendees aged 18+
• A complaint of nausea of at least 1 on a scale of 0 to 10 (11-point scale, where 0 represents "no nausea" and 10 represents "worst nausea imaginable").

You may not qualify if:

• Known allergy to isopropyl alcohol (standard practice involves medical team members asking patients what allergies they have; we will not directly ask about isopropyl alcohol in order to keep participants blinded to interventions)
• Inability to inhale through the nares (e.g. distorted nasal anatomy, active nosebleed, obstructed nasal passages, rhinitis, anosmia)
• Inability to verbally report level of nausea
• Prior administration of an oral or intravenous anti-nauseant (e.g. metoclopramide, ondansetron, dimenhydrinate) by festival medical staff since arrival at the festival (would confound treatment effect)

Sponsors & Collaborators

• Anthony Seto: lead

Study Sites (9)

Badlands Music Festival

Calgary, Alberta, Canada

Location

Chasing Summer Music Festival

Calgary, Alberta, Canada

Location

Family Reunion Music Festival

Calgary, Alberta, Canada

Location

Bomfest Music Festival

Edmonton, Alberta, Canada

Location

Hard West Music Festival

Wimborne, Alberta, Canada

Location

Electronic dance music festivals in Calgary

Calgary, Canada

Location

Electronic dance music festivals in Edmonton

Edmonton, Canada

Location

Electronic dance music festivals in Toronto

Toronto, Canada

Location

Electronic dance music festivals in Vancouver

Vancouver, Canada

Location

Related Publications (3)

• April MD, Oliver JJ, Davis WT, Ong D, Simon EM, Ng PC, Hunter CJ. Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):184-193. doi: 10.1016/j.annemergmed.2018.01.016. Epub 2018 Feb 17.

  PMID: 29463461 BACKGROUND

• Beadle KL, Helbling AR, Love SL, April MD, Hunter CJ. Isopropyl Alcohol Nasal Inhalation for Nausea in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2016 Jul;68(1):1-9.e1. doi: 10.1016/j.annemergmed.2015.09.031. Epub 2015 Dec 8.

  PMID: 26679977 BACKGROUND

• Merritt BA, Okyere CP, Jasinski DM. Isopropyl alcohol inhalation: alternative treatment of postoperative nausea and vomiting. Nurs Res. 2002 Mar-Apr;51(2):125-8. doi: 10.1097/00006199-200203000-00009.

  PMID: 11984383 BACKGROUND

MeSH Terms

Conditions

Nausea

Interventions

2-Propanol; Ethanol; Protein-Arginine Deiminases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Anthony V Seto, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An intervention/care provider will remove the packaging so that participants will be unable to identify the inhaled substance. We acknowledge that the smell of isopropyl alcohol may be familiar and thus identifiable for some treatment arm participants. However, participants will not be informed of the identity of the treatment and placebo during the consent process, instead only being told that we are comparing two inhaled substances to assess their relative effectiveness. Thus, recognizing they are inhaling isopropyl alcohol should not bias participants' responses, given they will not know whether isopropyl alcohol is a treatment or control. The outcomes assessor will be blinded, because the randomization and intervention delivery are both completed by the intervention/care provider, who will not be involved in screening/baseline assessment nor outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Course Chair, "Intro to Clinical Practice"

Model Details: Participants in Arm 1 will nasally inhale an isopropyl alcohol pad with 10 inhalations (intervention). Participants in Arm 2 will nasally inhale a sterile saline pad of similar appearance with 10 inhalations (placebo).

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: July 12, 2021
• Primary Completion: October 27, 2024
• Study Completion: October 27, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)