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Recruiting Phase 2, Phase 3 NCT05418244

Inhaled Isopropyl Alcohol for Treatment of Nausea

Trial Parameters

Condition Vomiting
Sponsor State University of New York at Buffalo
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 84
Sex ALL
Min Age 7 Years
Max Age 17 Years
Start Date 2022-04-20
Completion 2026-06-30
Interventions
Inhaled Isopropyl AlcoholOral OndansetronInhaled Placebo

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Patients with a chief complaint of nausea or vomiting * Ages 7-178 years, both sexes * Weight ≥ 15 kg * Baxter Animated Retching Faces (BARF) nausea severity score ≥ 4/10 Exclusion Criteria: * 1\. Require IV access * Inability to breathe in/out through the nose * Anosmia (self- or parental report) * Allergy to isopropyl alcohol or ondansetron * Current or history of alcohol abuse * Inability to communicate feeling nauseous * Inability to follow directions regarding taking deep breaths through the nose * Known prolonged QT interval * Pregnancy * Received antiemetics within the last 8 hours * Currently taking apomorphine

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