NCT02760069

Brief Summary

This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

July 23, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

April 15, 2016

Results QC Date

July 8, 2019

Last Update Submit

July 12, 2020

Conditions

Nausea

Outcome Measures

Primary Outcomes (1)

  • Nausea 100 mm Visual Analogue Scale (VAS)

    Full Scale Name: Nausea 100-mm visual analogue scale. Scale Construct: Measures nausea as reported by the patient Scale Range: Minimum is 0 (no nausea) to 100 (worst nausea imaginable). These values quantify, on an interval scale anchored at 0, the patient's subjective sensation of nausea. Higher values represent worse outcomes (e.g., more nausea). Patient makes a single vertical mark on a 100 mm horizontal line with 0 at the left and 100 on the right to depict their nausea.

    30 minutes post intervention

Secondary Outcomes (1)

  • Number of Participants Who Required Rescue Anti-emetics

    Study duration (up to 5 hours post intervention)

Study Arms (3)

Inhaled ISO + oral ondansetron

ACTIVE COMPARATOR

Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).

Drug: Inhaled isopropyl alcoholDrug: Oral ondansetron

Inhaled ISO + oral placebo

EXPERIMENTAL

Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.

Drug: Inhaled isopropyl alcoholDrug: Oral placebo

Inhaled placebo + oral ondansetron

ACTIVE COMPARATOR

Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.

Drug: Oral ondansetronDrug: Inhaled normal saline

Interventions

Inhaled isopropyl alcoholDRUG

Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.

Also known as: ISO
Inhaled ISO + oral ondansetronInhaled ISO + oral placebo
Oral ondansetronDRUG

Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.

Also known as: Ondansetron
Inhaled ISO + oral ondansetronInhaled placebo + oral ondansetron
Inhaled normal salineDRUG

Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.

Also known as: Inhaled placebo
Inhaled placebo + oral ondansetron
Oral placeboDRUG

Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00

Also known as: Oral sugar water
Inhaled ISO + oral placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 18 and older
  • complaint of nausea and/or vomiting reported at 3 or above on verbal numerical rating scale at the time of triage

You may not qualify if:

  • allergy to isopropyl alcohol or ondansetron
  • inability to breathe through nose (e.g., recent upper respiratory infection)
  • intake of cefoperazone, disulfiram, or metronidazole within the last 24 hours
  • mental status precluding informed consent including intoxication
  • known QT-prolongation
  • clinical suspicion for serotonin syndrome
  • intravenous catheter in place prior to study start
  • medications administered since patient arrival (e.g., in triage)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (4)

  • Beadle KL, Helbling AR, Love SL, April MD, Hunter CJ. Isopropyl Alcohol Nasal Inhalation for Nausea in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2016 Jul;68(1):1-9.e1. doi: 10.1016/j.annemergmed.2015.09.031. Epub 2015 Dec 8.

    PMID: 26679977BACKGROUND

  • Hines S, Steels E, Chang A, Gibbons K. Aromatherapy for treatment of postoperative nausea and vomiting. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD007598. doi: 10.1002/14651858.CD007598.pub2.

    PMID: 22513952BACKGROUND

  • Egerton-Warburton D, Meek R, Mee MJ, Braitberg G. Antiemetic use for nausea and vomiting in adult emergency department patients: randomized controlled trial comparing ondansetron, metoclopramide, and placebo. Ann Emerg Med. 2014 Nov;64(5):526-532.e1. doi: 10.1016/j.annemergmed.2014.03.017. Epub 2014 May 10.

    PMID: 24818542BACKGROUND

  • April MD, Oliver JJ, Davis WT, Ong D, Simon EM, Ng PC, Hunter CJ. Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):184-193. doi: 10.1016/j.annemergmed.2018.01.016. Epub 2018 Feb 17.

    PMID: 29463461DERIVED

MeSH Terms

Conditions

Nausea

Interventions

EthanolOndansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Results Point of Contact

Title
Dr. Michael D. April
Organization
Brooke Army Medical Center
Michael.D.April.mil@mail.mil
210-916-0808

Study Officials

  • Michael D April, MD, PhD, MSc

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Program Director for Research

Study Record Dates

First Submitted

April 15, 2016

First Posted

May 3, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

July 23, 2020

Results First Posted

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)