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

REB20-0288

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.

2021-07-12

2025-12-31

2026-01-30

Recruiting

70

Inclusion Criteria: * 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"). Exclusion Criteria: * 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "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.\n\nThe 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.", 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2024-05-08