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Inhaled Isopropyl Alcohol for Nausea

Phase 2 & 3

Recruiting

Led By Alana Koehler, MD

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight ≥ 15 kg

Ages 7-178 years, both sexes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes post-intervention as compared to baseline

Awards & highlights

Study Summary

This trial is testing if inhaled isopropyl alcohol can treat nausea and vomiting better than the conventional ondansetron treatment or placebo.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Inhaling isopropyl alcohol might cause irritation in the nose or lungs and dizziness. Ondansetron could lead to headaches, constipation or diarrhea, fatigue and sometimes serious heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 15 kg.

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I am between 7 and 178 years old.

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I am mainly experiencing nausea or vomiting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes post-intervention as compared to baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes post-intervention as compared to baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes post-intervention as compared to baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Nausea Score at 10 Minutes

Change in Nausea Score at 30 Minutes

Change in Nausea Score at Discharge

Secondary outcome measures

Length of Stay

Nurse Satisfaction in Ease of Administering the Treatment

Parent/Caregiver Satisfaction

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Inhaled Isopropyl AlcoholExperimental Treatment1 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 OndansetronActive Control1 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 PlaceboPlacebo Group1 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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor

246 Previous Clinical Trials

49,424 Total Patients Enrolled

1 Trials studying Nausea

40 Patients Enrolled for Nausea

Alana Koehler, MDPrincipal InvestigatorSUNY Buffalo

Heather Territo, MDStudy DirectorSUNY Buffalo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this research project prohibit those who are 50 or older from participating?

"This trial is looking for participants that are younger than 17 but older than 7 years old."

Answered by AI

What outcomes is this research looking to realize?

"The purpose of this clinical trial is to observe the change in nausea score 10 minutes post-intervention. This will be compared against a baseline time frame. Additionally, nurse satisfaction in administering the treatment, number of vomiting episodes, and length of stay will be evaluated as secondary outcomes."

Answered by AI

Are people who are sick able to join this trial currently?

"From what is publicly available on clinicaltrials.gov, it appears that this study is still recruiting patients. The trial was first advertised on April 20th, 2022 and was last updated on June 12th, 2022."

Answered by AI

Who is this clinical study most suited for?

"This study, which is currently enrolling, requires that participants be parents between the ages of 7 and 17. Additionally, patients must have a BMI of greater than 15, a BARF score of 4 or higher, and be experiencing nausea or vomiting."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inhaled Isopropyl Alcohol for Treatment of Nausea

Susana Ruano 2022. "Inhaled Isopropyl Alcohol for Treatment of Nausea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05418244.

All > Cyclic Vomiting Syndrome