Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)

Texas Tech University Health Sciences Center, El Paso

Status and phase: Completed; Early Phase 1

Conditions: Vomiting; Nausea

Treatments: Other: Inhaled Isopropyl Alcohol (IPA); Drug: Oral Dissolvable Tablet Zofran (ondansetron)

Study type: Interventional

Funder types: Other

Identifiers

NCT03125811

E17005

Details and patient eligibility

About

This study will compare two different ways to relieve nausea and vomiting in the Emergency Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.

Full description

Emergency physicians commonly use medications to alleviate nausea and vomiting. The medication Ondansetron is used in the emergency department and after surgery for this purpose. Inhaled isopropyl alcohol has been successfully used to decrease nausea and vomiting after surgery. No trial has compared inhaled isopropyl alcohol to Ondansetron in a clinical trial.

The author proposes to prospectively investigate extension of the established antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea in Emergency Department patients to the 30-minute post-intervention point that has been reported to be the frequent juncture of symptom relief. By introducing prolonged intervention, and re-dosing of established benefit, into this research, the author aims to reproduce the sustained antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea as demonstrated for post-operative nausea and vomiting.

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-65 years presenting to the emergency department complaining of current nausea with or without episodes of emesis beginning within the previous 24hrs

Exclusion criteria

• Patients with known allergy to isopropyl alcohol
• Patients outside of the defined age range
• Patients with an inability to inhale through the nares (including recent upper respiratory infection)
• Patients greater than 20 weeks estimated gestation
• Patients with past medical history of gastroparesis, or hemoptysis
• Patients who have taken an antiemetic medication in the past 48 hours
• Patients demonstrating hemodynamic instability with systolic blood pressure <90 or tachycardia >120 bpm

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Inhaled Isopropyl Alcohol (IPA)

Active Comparator group

Description:

Inhaled Isopropyl Alcohol (alcohol prep pad)

Treatment:

Other: Inhaled Isopropyl Alcohol (IPA)

Oral Dissolvable Tablet Zofran (OZ)

Other group

Description:

4 mg Oral Dissolvable Tablet Zofran (ondansetron)

Treatment:

Drug: Oral Dissolvable Tablet Zofran (ondansetron)