Using inhaled isopropyl alcohol to treat nausea in children
Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department: A Open Label, Randomized Controlled Clinical Trial
This study is testing if inhaling isopropyl alcohol can help reduce nausea in children better than the usual treatment with oral ondansetron or a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05418244 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of inhaled isopropyl alcohol in alleviating nausea and vomiting in pediatric patients compared to the standard treatment with oral ondansetron and a placebo. Eligible participants, aged 7 to 178 years, will be randomly assigned to one of three treatment groups: inhaled isopropyl alcohol, oral ondansetron, or inhaled normal saline. The study will take place in a pediatric emergency department, where informed consent will be obtained from the legal guardians before enrollment. The primary outcome will be the reduction of nausea severity as measured by the Baxter Animated Retching Faces (BARF) score.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 7 to 178 years who present with nausea or vomiting and meet specific inclusion criteria.
Not a fit: Patients who have a history of alcohol abuse, are pregnant, or have certain medical conditions such as prolonged QT interval will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing nausea in children, potentially improving their comfort and recovery.
How similar studies have performed: While the use of inhaled isopropyl alcohol for nausea is a novel approach, similar studies have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Buffalo, New York
- Oishei Children's Hospital — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Alana Koehler, MD — SUNY Buffalo
- Study coordinator: Haiping Qiao, MBBS, MS
- Email: hqiao@upa.chob.edu
- Phone: 7163230055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.