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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

Must not have

Currently taking apomorphine

Inability to breathe in/out through the nose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes post-intervention as compared to baseline

Awards & highlights

All Individual Drugs Already Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking apomorphine.

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I cannot breathe through my nose.

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I cannot follow instructions on taking deep breaths through my nose.

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I cannot smell anything.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Nausea Score at 10 Minutes

Change in Nausea Score at 30 Minutes

Change in Nausea Score at Discharge

Secondary study objectives

Length of Stay

Nurse Satisfaction in Ease of Administering the Treatment

Parent/Caregiver Satisfaction

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 / 7Eligibility criteria met