Inhaled Isopropyl Alcohol for Treatment of Nausea

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT05418244
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Children, Only
  • Nausea
  • Vomiting

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Accepted

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
  • Oral Ondansetron — DRUG
    4 mg oral disintegrating ondansetron tablet once
  • Inhaled Placebo — OTHER
    Normal saline pad (Hygea sterile saline wipe) held 1-2 cm under the subject's nares

Study Details

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.

Key Dates

Start date
Apr 20, 2022
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in Nausea Score at 30 Minutes [ Time Frame: 30 minutes post-intervention as compared to baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oishei Children's HospitalBuffaloNew York14203
Haiping Qiao
[email protected]
7163230055

Find similar trials in Buffalo, NY

By research site
Oishei Children's Hospital· Buffalo, NY

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