Inhaled Isopropyl Alcohol for Nausea

Recruiting at 8 trial locations

Overseen By Anthony V Seto, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anthony Seto

Must not be taking: Anti-nauseants

Disqualifiers: Allergy to isopropyl alcohol, others

Compensation: Varies

Number of Visits: 4

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have already taken an anti-nausea medication at the festival.

What data supports the effectiveness of the treatment Inhaled Isopropyl Alcohol for Nausea?

Research shows that inhaling isopropyl alcohol may help reduce nausea in some cases, as seven out of thirteen studies found it more effective than a placebo. However, the overall quality of evidence is low, and more studies are needed to confirm its effectiveness. ^{1 2 3 4 5}

Is inhaled isopropyl alcohol safe for humans?

Inhaled isopropyl alcohol has been studied for treating nausea, and no adverse effects were reported in the studies reviewed. However, the overall quality of evidence is low, and more research is needed to confirm its safety. ^{1 2 3 4 6}

How does inhaled isopropyl alcohol differ from other treatments for nausea?

Inhaled isopropyl alcohol is unique because it is administered through nasal inhalation, offering a quick and non-invasive way to relieve nausea, especially in emergency settings. Unlike traditional anti-nausea drugs, it does not have known adverse effects and can be used when other treatments like serotonin antagonists are ineffective. ^{1 2 4 5 6}

Research Team

Anthony V Seto, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adult attendees at a Canadian electronic dance music festival who are feeling nauseous. They must be able to inhale through their nose and report on their nausea level, but can't join if they've already taken anti-nausea medicine, have an allergy to isopropyl alcohol, or can't breathe through their nose.

Inclusion Criteria

I experience some level of nausea.

Exclusion Criteria

I am allergic to isopropyl alcohol.

I cannot breathe through my nose due to a condition or obstruction.

You cannot tell the doctor how much nausea you are feeling.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Intervention

Participants are randomized to inhale either isopropyl alcohol or sterile saline pads for nausea management

1 day

1 visit (in-person)

Immediate Follow-up

Participants' nausea levels are assessed 10 minutes post-inhalation

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and the need for rescue medication

10 minutes

1 visit (in-person)

Treatment Details

Interventions

• Inhaled Isopropyl Alcohol
• Placebo

Trial Overview The study tests whether sniffing an isopropyl alcohol pad helps with nausea more than a placebo (sterile saline pad). Participants will take 10 deep sniffs from the pad and then rate their nausea after 10 minutes. The main goal is to see if there's a difference in how nauseous they feel.

Participant Groups

Group I: Isopropyl Alcohol Experimental Treatment 1 Intervention

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

Group II: Sterile Saline Placebo Group 1 Intervention

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

Inhaled Isopropyl Alcohol is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Isopropyl Alcohol for:

• Antiseptic
• Disinfectant
• Hand sanitizer

Approved in European Union as Isopropyl Alcohol for:

• Antiseptic
• Disinfectant
• Hand sanitizer
• Medical device cleaning

Approved in Canada as Isopropyl Alcohol for:

• Antiseptic
• Disinfectant
• Hand sanitizer

Approved in Japan as Isopropyl Alcohol for:

• Antiseptic
• Disinfectant
• Hand sanitizer

Approved in China as Isopropyl Alcohol for:

• Antiseptic
• Disinfectant
• Hand sanitizer

Approved in Switzerland as Isopropyl Alcohol for:

• Antiseptic
• Disinfectant
• Hand sanitizer

Who Is Running the Clinical Trial?

Anthony Seto

Lead Sponsor

Trials

1

Recruited

70+

Findings from Research

In a study of 84 emergency department patients, nasal inhalation of isopropyl alcohol significantly reduced nausea compared to a placebo, with a median nausea score of 3 versus 6 at 10 minutes post-treatment.

Patients who inhaled isopropyl alcohol reported higher satisfaction levels (median score of 4) compared to those who received the placebo (median score of 2), indicating that isopropyl alcohol is not only effective in alleviating nausea but also improves patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isopropyl Alcohol Nasal Inhalation for Nausea in the Emergency Department: A Randomized Controlled Trial. Beadle, KL., Helbling, AR., Love, SL., et al.[2018]

Inhaled isopropyl alcohol (IPA) was evaluated in 13 randomized controlled trials involving 1253 participants for its effectiveness in managing nausea and vomiting, particularly in postoperative and emergency settings.

While some studies reported IPA as more effective than other treatments, the overall quality of evidence was low, and no adverse effects were noted, indicating a need for further research to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalation of Isopropyl Alcohol for the Management of Nausea and Vomiting: A Systematic Review. Erdogan-Ongel, E., Heung, Y., Rozman de Moraes, A., et al.[2023]

Inhaled isopropyl alcohol (IPA) has been found to significantly reduce nausea in adults presenting to the emergency department, with a mean reduction of 2.18 on a 0-10 scale compared to placebo, indicating its potential efficacy as an antiemetic.

However, the evidence is considered moderate due to the small number of trials (only two included in the primary analysis with 195 patients), and further large-scale studies are needed to confirm these findings and assess its impact on vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isopropyl alcohol inhalation for the treatment of nausea in adult emergency department patients: a systematic review and meta-analysis. Lee, SY., Tamale, JR.[2023]

Inhaled isopropyl alcohol (IPA) significantly reduced the time to achieve a 50% reduction in nausea compared to 5-HT3 antagonists, with a mean difference of -20.06 minutes, based on a meta-analysis of 4 randomized controlled trials involving 382 participants.

IPA also resulted in a greater reduction in nausea scores at 30 minutes and decreased the need for rescue antiemetics, suggesting it may be a rapid and effective alternative for nausea relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isopropyl alcohol inhalation versus 5-HT3 antagonists for treatment of nausea: a meta-analysis of randomised controlled trials. Kimber, JS., Kovoor, JG., Glynatsis, JM., et al.[2023]

In a study involving 91 children aged 6-16 undergoing surgery, inhaling isopropyl alcohol vapor significantly reduced nausea and vomiting severity in 65% of the treatment group compared to 26% in the control group, indicating its potential effectiveness as a treatment.

However, the relief was temporary, as 54% of the treatment group experienced recurrent nausea or vomiting shortly after, suggesting that while isopropyl alcohol may provide short-term relief, it may not be a long-lasting solution for postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative method to alleviate postoperative nausea and vomiting in children. Wang, SM., Hofstadter, MB., Kain, ZN.[2022]

The introduction of isopropyl alcohol (IPA) for treating nausea in the emergency department significantly increased the percentage of patients receiving treatment from 66.0% to 97.1% and reduced the time to treatment initiation from 7 minutes to just 1 minute.

Using IPA led to a decrease in the use of conventional anti-emetics and reduced treatment costs from €1.33 to €0.67 per patient, indicating that IPA is a more efficient and cost-effective option for managing nausea in the ED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of isopropyl alcohol (IPA) inhalation as the first-line treatment for nausea in the emergency department: practical advantages and influence on the quality of care. Veldhuis, P., Melse, M., Mullaart, N.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Isopropyl Alcohol Nasal Inhalation for Nausea in the Emergency Department: A Randomized Controlled Trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Inhalation of Isopropyl Alcohol for the Management of Nausea and Vomiting: A Systematic Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Isopropyl alcohol inhalation for the treatment of nausea in adult emergency department patients: a systematic review and meta-analysis. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Isopropyl alcohol inhalation versus 5-HT3 antagonists for treatment of nausea: a meta-analysis of randomised controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

An alternative method to alleviate postoperative nausea and vomiting in children. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Implementation of isopropyl alcohol (IPA) inhalation as the first-line treatment for nausea in the emergency department: practical advantages and influence on the quality of care. [2021]