drugset / Trial / NCT04307550

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

NCT04307550

Completed 55 enrolled Anthony Seto
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-07-12
Primary completion
2024-10-27
Completion
2024-10-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Isopropyl alcohol Other / unclassified Intranasal

Indications

No indication recorded.