New treatment option for Vomiting
Official title Inhaled Isopropyl Alcohol for Treatment of Nausea
ClinicalTrials.gov ID: NCT05418244
What this study is testing
What is Oral Ondansetron?
Oral Ondansetron is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for vomiting.
Also referred to as Zofran.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.