Inhaled Isopropyl Alcohol for Nausea

Overseen By Haiping Qiao, MBBS, MS

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: State University of New York at Buffalo

Must not be taking: Antiemetics, Apomorphine

Disqualifiers: Alcohol abuse, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Up to 10 hours

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether inhaling isopropyl alcohol (rubbing alcohol) can reduce nausea and vomiting in children and teens, comparing it to ondansetron and a placebo. The main goal is to determine if this method is as effective or more effective in a busy pediatric emergency room setting. Participants who frequently experience nausea or vomiting and can breathe through their noses without issues may be suitable for this trial. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 taken antiemetics (medications that prevent nausea) in the last 8 hours or if you are currently taking apomorphine.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that inhaling isopropyl alcohol can cause side effects such as headaches, dizziness, and nausea. High exposure levels can lead to more serious effects, including extreme drowsiness or fainting. However, the amounts used in medical settings, such as in this trial, are typically much lower, resulting in generally mild side effects or none at all.

Since this trial is in the later stages, earlier research has demonstrated that inhaled isopropyl alcohol is somewhat safe and tolerated. In this trial, inhaled isopropyl alcohol is compared to ondansetron, a medication already approved for treating nausea and generally considered safe for children. Participants should discuss any concerns with the medical team before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard oral treatments for nausea, like ondansetron, inhaled isopropyl alcohol offers a unique delivery method that acts quickly. Researchers are excited about this treatment because inhaling isopropyl alcohol pads can provide almost instant relief, which is particularly beneficial in acute settings like the Emergency Department. This method bypasses the digestive system, allowing for rapid action and potentially fewer side effects compared to oral medications. Additionally, it uses a simple and accessible ingredient, making it an innovative option for managing nausea.

What evidence suggests that this trial's treatments could be effective for nausea?

Research has shown that inhaling isopropyl alcohol can help reduce nausea. In this trial, participants may receive inhaled isopropyl alcohol, which previous studies have demonstrated to be effective for mild to moderate nausea and vomiting. One study found it worked better than a placebo in just 10 minutes. In some cases, it was as effective as ondansetron, a common anti-nausea drug. Many patients reported feeling better after using it. These findings suggest that inhaling isopropyl alcohol may effectively manage nausea. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather Territo, MD

Principal Investigator

SUNY Buffalo

Alana Koehler, MD

Principal Investigator

SUNY Buffalo

Are You a Good Fit for This Trial?

This trial is for kids and teens aged 7-17 who feel very nauseous, weigh at least 15 kg, and haven't taken anti-nausea medicine in the last 8 hours. It's not for those who can't breathe through their nose, follow breathing instructions, have certain heart issues or allergies to the study drugs, are pregnant, have a history of alcohol abuse or can't say if they're feeling sick.

Inclusion Criteria

Baxter Animated Retching Faces (BARF) nausea severity score ≥ 4/10

I weigh at least 15 kg.

I am between 7 and 178 years old.

Exclusion Criteria

Known prolonged QT interval

Allergy to isopropyl alcohol or ondansetron

I am currently taking apomorphine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either inhaled isopropyl alcohol, oral ondansetron, or inhaled placebo for nausea treatment

Up to 10 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in nausea score and satisfaction until ED discharge

Up to 10 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inhaled Isopropyl Alcohol
• Inhaled Placebo
• Oral Ondansetron

Trial Overview The study tests if sniffing isopropyl alcohol helps with nausea better than swallowing ondansetron (a common anti-nausea drug) or inhaling a placebo. Participants will be randomly assigned to one of these treatments in an emergency department setting.

How Is the Trial Designed?

Group I: Inhaled Isopropyl Alcohol Experimental Treatment 1 Intervention

If the subject is assigned to receive the isopropyl alcohol pad group, an isopropyl alcohol pad (Covidien Webcol 2 ply prep pad, saturated with 70% isopropyl alcohol) will be given to the subject, or the legal guardian. The alcohol pad will be held 1-2 cm under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed during the Emergency Department (ED) stay.

Group II: Oral Ondansetron Active Control 1 Intervention

If the subject is assigned to receive ondansetron treatment, subject will be provided with 4 mg ondansetron oral disintegrating tablet (ODT) for treatment.

Group III: Inhaled Placebo Placebo Group 1 Intervention

If the subject is assigned to receive the inhaled placebo, a normal saline pad (Hygea sterile saline wipe) will be given to the subject or the legal guardian. The saline wipe will be held under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed.

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?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

Inhalation of 70% isopropyl alcohol (IPA) significantly improved control of postoperative nausea and vomiting (PONV) in 208 maxillofacial surgery patients compared to those receiving only ondansetron, with better scores observed at 4, 6, and 8 hours post-surgery.

The study demonstrated that adding IPA inhalation to the standard anti-nausea treatment was effective, suggesting a potential new approach for managing PONV in patients undergoing general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of Postoperative Nausea and Vomiting in Oral and Maxillofacial Surgery Patients with Isopropyl Alcohol: A Prospective Randomized Clinical Trial. Verma, DK., Bansal, S., Sharma, P., et al.[2022]

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]

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]

Inhalation of isopropyl alcohol has been observed as a practical and cost-effective method for treating postoperative nausea and vomiting, based on anecdotal evidence from recovery room practices.

The use of readily available alcohol preparation pads as a nursing intervention could provide an alternative to more expensive antiemetic medications, warranting further investigation into its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isopropyl alcohol inhalation as treatment for nausea and vomiting. Spencer, KW.[2019]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6189884/

Inhaled isopropyl alcohol for nausea and vomiting in the ... Two trials with about 200 nonpregnant adults presenting to the ED found inhaled (smelling) isopropyl alcohol improved mild to moderate nausea and vomiting.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10435785/

Clinical experience with the use of inhaled isopropyl alcohol ... Inhalation of its vapor has been noted to potentially have antiemetic effects, which may be useful in the treatment of postoperative nausea and vomiting (PONV).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04307550?term=ISOPROPANOL&viewType=Table&rank=6

Inhaled Isopropyl Alcohol Versus Placebo to Manage ... A 2016 randomized controlled trial found that nasally inhaled isopropyl alcohol achieved better nausea relief compared to placebo during a 10-minute period.

4. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/14/2/e003189

Improving patient access to symptomatic treatment through ... 88% of respondents felt there was improvement in symptoms. There were very limited participants (12%) who reported that IPA administration ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067991X24001688

Evaluation of Isopropyl Alcohol Aromatherapy in Treating ... In this study, there was no difference between intravenous ondansetron and IPA aromatherapy in the proportion of HEMS patients reporting improvement in nausea.

6. airgas.com airgas.com/msds/001105.pdf

Isopropyl Alcohol nausea or vomiting headache drowsiness/fatigue ... Inhalation (gases). 22624 ppm. Route. ATE value. Acute toxicity estimates. Potential immediate effects.

7. nrf.aux.eng.ufl.edu nrf.aux.eng.ufl.edu/_files/msds/2/Isopropyl%20Alcohol.pdf

Material Safety Data Sheet Isopropyl Alcohol, 50-100% v/v May cause central nervous system depression, characterized by excitement, followed by headache, dizziness, drowsiness, and nausea. Advanced stages may cause ...

8. sigmaaldrich.com sigmaaldrich.com/sds/sigma/i9516?srsltid=AfmBOopVdOOFvBR0vr4zAzGtBVbQT51FvJ0otBgzAKYWLC2OnHTKQbJu

• SAFETY DATA SHEET Central nervous system depression, prolonged or repeated exposure can cause:, Nausea, ... Poison Inhalation Hazard : No. Page 14. Sigma - I9516.

9. medline.com medline.com/media/catalog/Docs/MSDS/MSD_SDS0200.pdf

Safety Data Sheet Inhalation: Inhalation of high concentrations may cause central nervous system effects characterized by nausea, headache, dizziness, unconsciousness and coma.

10. phoenixproductsco.com phoenixproductsco.com/wp-content/uploads/2015/10/Isopropyl-Alcohol-99-2670.pdf

SAFETY DATA SHEET Isopropyl Alcohol 99% - 2670 Ingestion: May be harmful if swallowed. Inhalation: May be harmful if inhaled. Causes respiratory tract irritation. Vapors may cause drowsiness and dizziness.