Inhaled Isopropyl Alcohol Versus Placebo to Manage Nausea at Electronic Dance Music Festivals
Status:
Recruiting
Trial end date:
2023-04-20
Target enrollment:
Participant gender:
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
Albertan 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.