Inhaled Isopropyl Alcohol for Treatment of Nausea

NCT05418244 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 00005944
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Vomiting; Nausea; Children, Only

Outcome Measures

Primary Outcomes (3)

• Change in Nausea Score at 30 Minutes

  Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea

  30 minutes post-intervention as compared to baseline

• Change in Nausea Score at 10 Minutes

  Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea

  10 minutes post-interventnon as compared to baseline

• Change in Nausea Score at Discharge

  Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea

  At ED discharge (assessed up to 10 hours) as compared to baseline

Secondary Outcomes (4)

• Vomiting

  From intervention to time of ED discharge (assessed up to 10 hours)

• Parent/Caregiver Satisfaction

  At time of ED discharge (assessed up to 10 hours)

• Nurse Satisfaction in Ease of Administering the Treatment

  At time of ED discharge (assessed up to 10 hours)

• Length of Stay

  From arrival to time of ED discharge (assessed up to 10 hours)

Study Arms (3)

Inhaled Isopropyl Alcohol

EXPERIMENTAL

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.

Other: Inhaled Isopropyl Alcohol

Oral Ondansetron

ACTIVE COMPARATOR

If the subject is assigned to receive ondansetron treatment, subject will be provided with 4 mg ondansetron oral disintegrating tablet (ODT) for treatment.

Drug: Oral Ondansetron

Inhaled Placebo

PLACEBO COMPARATOR

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.

Other: Inhaled Placebo

Interventions

Inhaled Isopropyl Alcohol OTHER

Isopropyl alcohol pad (Covidien Webcol 2 ply prep pads, saturated with 70% isopropyl alcohol) held 1-2 cm under the subject's nares

Also known as: Webcol

Inhaled Isopropyl Alcohol

Oral Ondansetron DRUG

4 mg oral disintegrating ondansetron tablet once

Also known as: Zofran

Oral Ondansetron

Inhaled Placebo OTHER

Normal saline pad (Hygea sterile saline wipe) held 1-2 cm under the subject's nares

Also known as: Inhaled Normal Saline'

Inhaled Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Oishei Children's Hospital

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Ethanol; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Alana Koehler, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

• Heather Territo, MD

  SUNY Buffalo

  STUDY DIRECTOR

Central Study Contacts

Haiping Qiao, MBBS, MS

CONTACT

7163230055; hqiao@upa.chob.edu

Alana Koehler, MD

CONTACT

315576264; alanakoe@buffalo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 14, 2022
• Study Start: April 20, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (1)