NCT05418244 Inhaled Isopropyl Alcohol for Treatment of Nausea
| NCT ID | NCT05418244 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | State University of New York at Buffalo |
| Condition | Vomiting |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2022-04-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2022-04-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Alana Koehler, MD
PRINCIPAL INVESTIGATOR
SUNY Buffalo
Frequently Asked Questions
Who can join the NCT05418244 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Vomiting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05418244 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05418244 currently recruiting?
Yes, NCT05418244 is actively recruiting participants. Contact the research team at hqiao@upa.chob.edu for enrollment information.
Where is the NCT05418244 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT05418244 clinical trial?
NCT05418244 is sponsored by State University of New York at Buffalo. The principal investigator is Alana Koehler, MD at SUNY Buffalo. The trial plans to enroll 84 participants.