RecruitingPhase 2Phase 3NCT05418244

Inhaled Isopropyl Alcohol for Treatment of Nausea

Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department: A Open Label, Randomized Controlled Clinical Trial


Sponsor

State University of New York at Buffalo

Enrollment

84 participants

Start Date

Apr 20, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 7 YearsMax Age: 17 Years

Inclusion Criteria4

  • 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 Criteria11

  • \. 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

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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


Locations(1)

Oishei Children's Hospital

Buffalo, New York, United States

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NCT05418244


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