Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department: A Open Label, Randomized Controlled Clinical Trial
State University of New York at Buffalo
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.
Description
I. Obtaining consent Our study personnel will approach the treating physician in the ED once a patient is suspected to be eligible for the study. The physician will determine patient's eligibility by using the screening sheet. If a patient meets all study inclusion and exclusion criteria, our study personnel will approach the legal guardian/patient in the private patient room and introduce the study to them. Enough time will be given to the patient and their legal guardian to allow them review and understand the consent/assent. All questions will be answered before obtaining the consent. Once…
Eligibility
- Age range
- 7–17 years
- Sex
- All
- Healthy volunteers
- Yes
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 wit…
Interventions
- OtherInhaled Isopropyl Alcohol
Isopropyl alcohol pad (Covidien Webcol 2 ply prep pads, saturated with 70% isopropyl alcohol) held 1-2 cm under the subject's nares
- DrugOral Ondansetron
4 mg oral disintegrating ondansetron tablet once
- OtherInhaled Placebo
Normal saline pad (Hygea sterile saline wipe) held 1-2 cm under the subject's nares
Location
- Oishei Children's HospitalBuffalo, New York