Inhaled Isopropyl Alcohol for Nausea

Overseen by Alana Koehler, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: State University of New York at Buffalo

Must not be taking: Antiemetics, Apomorphine

Disqualifiers: Alcohol abuse, Pregnancy, others

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

To determine the efficacy of inhaled isopropyl alcohol in treating nausea/vomiting among pediatric patients compared with the conventional ondansetron, or placebo treatment in a tertiary care pediatric emergency department.

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.

What data supports the effectiveness of inhaled isopropyl alcohol as a treatment for nausea?

Research suggests that inhaling isopropyl alcohol may help reduce nausea, especially after surgery, as some studies found it more effective than other treatments. However, the overall quality of evidence is low, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is inhaled isopropyl alcohol safe for humans?

In studies involving 1253 participants, inhaled isopropyl alcohol was used to treat nausea and no adverse effects were reported, suggesting it is generally safe for humans. ^{1 2 3 6 7}

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

Inhaled isopropyl alcohol is unique because it is administered through inhalation, providing a simple and cost-effective alternative to traditional anti-nausea medications. It is often used in settings like recovery rooms and emergency departments, where it can quickly alleviate nausea without the need for more expensive drugs. ^{1 2 3 4 5}

Research Team

Alana Koehler, MD

Principal Investigator

SUNY Buffalo

Heather Territo, MD

Principal Investigator

SUNY Buffalo

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Inhaled Isopropyl Alcohol (Other)
• Inhaled Placebo (Other)
• Oral Ondansetron (Anti-emetic)

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.

Participant Groups

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 Canada, Japan, China, Switzerland for the following indications:

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+

Dr. Jonathan Slonin

State University of New York at Buffalo

Chief Medical Officer since 2020

MD from University of Miami, MBA from George Washington University

Stacy Knapper

State University of New York at Buffalo

Chief Executive Officer since 2023

BSEE from University of Puerto Rico-Mayagüez, MS in Management from Rensselaer Polytechnic Institute

Findings from Research

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]

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]

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]

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]

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]

References

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

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

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

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]

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

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

5. India 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. [2022]

6. 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]

7. 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]