Recruiting
Phase 2
Phase 3

Isopropyl Alcohol

Sponsor:

State University of New York at Buffalo

Code:

NCT05418244

Conditions

Vomiting

Nausea

Children, Only

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Interventions

Inhaled Isopropyl Alcohol

Oral Ondansetron

Inhaled Placebo

Study Details

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

Study ID

NCT05418244

Start date

Apr 20, 2022

Status verified date

Oct, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inhaled Isopropyl Alcohol

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.

active comparator: Oral Ondansetron

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

placebo comparator: Inhaled Placebo

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.

Interventions

Inhaled Isopropyl Alcohol

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

Oral Ondansetron

4 mg oral disintegrating ondansetron tablet once

Inhaled Placebo

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

Primary outcome measure

  • Change in Nausea Score at 30 Minutes [ Time Frame: 30 minutes post-intervention as compared to baseline ]
  • Change in Nausea Score at 10 Minutes [ Time Frame: 10 minutes post-interventnon as compared to baseline ]
  • Change in Nausea Score at Discharge [ Time Frame: At ED discharge (assessed up to 10 hours) as compared to baseline ]

Central Contacts and Locations

Central contacts

Haiping Qiao, MBBS, MS

7163230055hqiao@upa.chob.edu

Alana Koehler, MD

315576264alanakoe@buffalo.edu

Locations

Oishei Children's Hospital

Recruiting

Buffalo, New York, United States, 14203

Contacts

Haiping Qiao

7163230055hqiao@upa.chob.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2025-10-08.