Clinical Trial: Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Nasally Inhaled Isopropyl Alcohol Versus Oral Ondansetron for the Treatment of Nausea in the Emergency Department: A Double-Blind Randomized Controlled Trial

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.

Detailed Summary:

This study is a prospective randomized controlled trial to test the hypothesis that nasally-inhaled isopropyl alcohol (ISO) plus oral placebo has greater anti-emetic efficacy compared to oral ondansetron oral solution. By design, the study will be double-blinded insofar as neither investigators nor subjects will be notified of the identity of the substances they are inhaling or swallowing. The study will include a post-study survey to ascertain the extent to which blinding was achieved. Potential subjects are those presenting to the Emergency Department (ED) with nausea and/or vomiting. Investigators will recruit a convenience sample by approaching subjects at the time of initial triage and solicit nausea on a verbal numerical rating scale (VNRS) scored from 0-10 with those patients reporting scores of 3 or greater eligible for study. Informed consent will be obtained from each subject.

Subjects will be allocated to one of three arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron. No subject will receive both inhaled and oral placebo; all subjects will be allocated to at least one therapeutic intervention for nausea. Both investigators and study subjects will be blinded to subject allocation.

Regarding the interventions, upon recruitment, patients will be administered an oral solution (placebo or ondansetron) by their treating nurse. A study team member will then instruct the subject to inhale one of the blinded prep pads, to hold the pad approximately 1 centimeter from their nares, and to take deep nasal inhalations as needed for nausea relief. The investigator will remain at arm's length from the patient at all times to avoid detecting prep pad scent. Additionally, investigators will also instruct subjects to avoid any behav
Sponsor: Brooke Army Medical Center

Current Primary Outcome: Nausea measured by patient written mark on 10 cm visual analogue scale (VAS) [ Time Frame: 30 minutes post intervention ]

Mark on 10 cm line ranging from "no nausea" on left to "worst nausea imaginable" on right (continuous variable)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Receipt of rescue anti-emetics measured by nursing drug administration record [ Time Frame: Study duration (up to 5 hours post intervention) ]
    Whether patient required rescue anti-emetics (binary variable)
  • Patient satisfaction measured by patient written mark on 10 cm visual analogue scale [ Time Frame: Study end (up to 5 hours post intervention) ]
    Mark on 10 cm line ranging from "completely unsatisfied" on left to "completely satisfied" on right (continuous variable)
  • Time to disposition measured by physician medical record entry [ Time Frame: Study duration (up to 5 hours post intervention) ]
    Time in minutes to provider decisions regarding patient disposition (continuous variable)
  • Patient vomiting determined by researcher observation [ Time Frame: Study duration (up to 5 hour post intervention) ]
    Whether patient vomiting during Emergency Department stay (binary variable)


Original Secondary Outcome: Same as current

Information By: Brooke Army Medical Center

Dates:
Date Received: April 15, 2016
Date Started: January 2016
Date Completion: May 2017
Last Updated: January 30, 2017
Last Verified: January 2017