NCT04464915

Brief Summary

Nausea and vomiting is a common and distressing presenting complaint in Canadian emergency departments. Commonly used nausea medications have proven to be effective in certain patient populations, for example cancer patients. However, not one has been proven to be more effective that the other in the emergency department setting. In addition, many are associated with significant side effects and have the potential to interact with a patient's home medications. This limits their use in the emergency department until the patient is seen and assessed by their treating physician. Many studies have shown that nasal inhalation of alcohol swabs is an effective therapy in relieving nausea and vomiting in post-operative patients after surgeries. The goal of this study will be to determine the effectiveness of alcohol swabs in the emergency department setting in relieving nausea and vomiting.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

March 6, 2020

Last Update Submit

September 28, 2022

Conditions

NauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • Change in nausea scores from pre-intervention to post-intervention

    Self-reported 10-point verbal numeric scale ranging from 1-10, labeled "no nausea" at the left end (1) and "worse nausea imaginable" at right end (10).

    From the time of randomization over two hours

Secondary Outcomes (4)

  • Subject satisfaction score

    From the time of randomization over two hours

  • Receipt of rescue anti-emetics

    From the time of randomization until the time of documented emergency department disposition (either admission to hospital or discharge home

  • Emergency department length of stay

    From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home)

  • Subject disposition

    From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home

Study Arms (3)

Isopropyl alcohol swab every 10 minutes

EXPERIMENTAL

One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes for a total of one hour.

Other: Isopropyl alcohol swab

Isopropyl alcohol swab every 20 minutes

EXPERIMENTAL

One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 20 minutes for a total of one hour.

Other: Isopropyl alcohol swab

No treatment arm

NO INTERVENTION

No intervention administered.

Interventions

Isopropyl alcohol swabOTHER

Treatment will be administered by taking one deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes or every 20 minutes for a total of one hour.

Isopropyl alcohol swab every 10 minutesIsopropyl alcohol swab every 20 minutes

Eligibility Criteria

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

You may qualify if:

  • Adult patients (age ≥18 years) presenting to the emergency department with a chief complaint of nausea and/or vomiting with a level of 3 or greater on a verbal numeric response scale (1-10).

You may not qualify if:

  • Not able to breathe through nares (ie. rhinitis)
  • Known pregnancy
  • Have already received an anti-emetic within the past 24 hours (including while in emergency department triage)
  • Chronic nausea (\> 1 month)
  • Known allergy to isopropyl alcohol
  • Nasally sensitive to inhaled chemical products
  • Altered mental status or underlying cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (6)

  • 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

  • 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

  • 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: 29463461BACKGROUND

  • Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Somerfield MR, Lyman GH. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261. doi: 10.1200/JCO.2017.74.4789. Epub 2017 Jul 31.

    PMID: 28759346BACKGROUND

  • Furyk JS, Meek RA, Egerton-Warburton D. Drugs for the treatment of nausea and vomiting in adults in the emergency department setting. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD010106. doi: 10.1002/14651858.CD010106.pub2.

    PMID: 26411330BACKGROUND

  • Patanwala AE, Amini R, Hays DP, Rosen P. Antiemetic therapy for nausea and vomiting in the emergency department. J Emerg Med. 2010 Sep;39(3):330-6. doi: 10.1016/j.jemermed.2009.08.060. Epub 2009 Dec 21.

    PMID: 20022195BACKGROUND

MeSH Terms

Conditions

NauseaVomiting

Interventions

Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Venkatesh Thiruganasambandomoorthy, MD

    Senior Scientist, Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The trial design is open label, given that blinding the scent of alcohol swabs is difficult. As such, no blinding of the study participants nor the research team to interventions will occur, as there will be no placebo intervention given.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

July 9, 2020

Study Start

July 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)