Actively Recruiting
Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department A Open Label, Randomized Controlled Clinical Trial
Led by State University of New York at Buffalo · Updated on 2025-10-08
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out how well inhaled isopropyl alcohol works to treat nausea and vomiting in children aged 7 to 17 years at a pediatric emergency department. It compares this treatment to the usual oral ondansetron medication and to a placebo using inhaled normal saline. This study is a randomized controlled trial designed to assess which treatment may help reduce nausea symptoms in this young patient group. Participants are randomly assigned to one of three groups: inhaled isopropyl alcohol, oral ondansetron tablets, or inhaled normal saline placebo. In the inhaled groups, the pad soaked with the assigned substance is held under the child's nose to inhale deeply during their stay in the emergency department. Those receiving the placebo or isopropyl alcohol may receive ondansetron if symptoms do not improve within 30 minutes. The treatment is given once, with monitoring throughout the emergency visit. During the study, researchers will collect data on nausea severity before treatment and at 10 minutes, 30 minutes, and at discharge using the Baxter Animated Retching Faces nausea score. They will also record vomiting episodes, any side effects, satisfaction from both caregivers and nurses, and length of stay in the emergency department. Data is securely stored and analyzed to understand treatment effects. The total participation time spans the emergency visit, which can be up to 10 hours.
CONDITIONS
Brief Title
Inhaled Isopropyl Alcohol for Treatment of Nausea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a chief complaint of nausea or vomiting
- Ages 7 to 17 years, both sexes
- Weight 15 kg or more
- Baxter Animated Retching Faces nausea severity score 4 or higher out of 10
You will not qualify if you...
- Require IV access
- Unable to breathe in or out through the nose
- Anosmia (loss of smell) reported by patient or parent
- Allergy to isopropyl alcohol or ondansetron
- Current or history of alcohol abuse
- Cannot communicate feeling nauseous
- Cannot follow instructions to take deep breaths through the nose
- Known prolonged QT interval heart condition
- Pregnancy
- Received antiemetics within the last 8 hours
- Currently taking apomorphine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to a few hours on the day of Emergency Department (ED) visit
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person in the ED)
Duration - During the Emergency Department stay (up to approximately 10 hours)
Participants receive one of three treatments: inhaled isopropyl alcohol, oral ondansetron tablet, or inhaled placebo during their stay in the Emergency Department. Participants using inhaled treatments will inhale through the nose as frequently as needed during their ED stay. If no improvement is observed after 30 minutes for inhaled treatments, ondansetron may be administered.
1 treatment visit (in-person in the ED)
Duration - Up to 10 hours during the Emergency Department visit
Participants are monitored for nausea symptoms and side effects with assessments at 10 minutes, 30 minutes post-intervention, and at ED discharge. Satisfaction scores are also collected from caregivers and nurses.
Assessments at 10 minutes, 30 minutes post-treatment, and at ED discharge (all in-person)
Trial Site Locations
Total: 1 location
1
Oishei Children's Hospital
Buffalo, New York, United States, 14203
Actively Recruiting
Research Team
H
Haiping Qiao, MBBS, MS
A
Alana Koehler, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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