Inhaled Isopropyl Alcohol for Treatment of Nausea

RECRUITING

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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.

Conditions:

🦠 Vomiting 🦠 Nausea 🦠 Children, Only

🗓️ Study Start (Actual) 20 April 2022

🗓️ Primary Completion (Estimated) 30 June 2024

✅ Study Completion (Estimated) 30 June 2024

👥 Enrollment (Estimated) 84

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Buffalo, New York, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 7 Years to 17 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 1 June 2022
First Submitted that Met QC Criteria 12 June 2022
First Posted 14 June 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 19 September 2023
Last Update Posted 21 September 2023
Last Verified September 2023