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

Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department

Sponsors

Lead sponsor: Brooke Army Medical Center

Source Brooke Army Medical Center
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 Description

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 behavior or actions during the study that would indicate which preparation pad is being used.

The investigators will record their findings on data collection forms. The primary outcome will be nausea as measured on a 10 cm visual analogue scale (VAS) at 30 minutes. Nausea measurements will also be collected at 10, 20, 40, 50, and 60 minutes, and then every hour up to 5 hours, then at disposition at which time the patient will provide one final nausea VAS score. The study team member will not be present in the patient's room during the intervals between these evaluations. At the time of each nausea measurement, patients will be offered another preparation pad (up to ten pads). Investigators will notify the patient's treating provider to prompt consideration for treatment with a rescue anti-emetic (such as metoclopramide or promethazine) if the patient vomits or if the patient requests an anti-emetic at any time. At the time of each nausea measurement, a pain score will also be measured on a 10 cm VAS. At the time of final disposition, the patient will provide a satisfaction score on a 10-cm VAS and be asked to indicate his/her belief as to whether the pad was a treatment or placebo and whether the oral solution was a treatment or placebo. Similarly, at study conclusion the patient's provider will be asked to indicate his/her belief as to whether the pad was a treatment or placebo and whether the oral solution was a treatment or placebo. Other data collected will include times and doses for all medications (including preparation pads) and fluids administered, episodes of vomiting (defined as forceful expulsion of gastric contents separated by at least 2 minutes), disposition (admission versus discharge), final clinical impression at the time of disposition, and time to disposition. Subjects will be followed and data collected for the entirety of their ED stay.

Overall Status Completed
Start Date January 2016
Completion Date November 2017
Primary Completion Date November 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Nausea measured by patient written mark on 10 cm visual analogue scale (VAS) 30 minutes post intervention
Secondary Outcome
Measure Time Frame
Receipt of rescue anti-emetics measured by nursing drug administration record Study duration (up to 5 hours post intervention)
Patient satisfaction measured by patient written mark on 10 cm visual analogue scale Study end (up to 5 hours post intervention)
Time to disposition measured by physician medical record entry Study duration (up to 5 hours post intervention)
Patient vomiting determined by researcher observation Study duration (up to 5 hour post intervention)
Enrollment 122
Condition
Intervention

Intervention type: Drug

Intervention name: Inhaled isopropyl alcohol

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

Other name: ISO

Intervention type: Drug

Intervention name: Oral ondansetron

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

Other name: Ondansetron

Intervention type: Drug

Intervention name: Inhaled normal saline

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

Arm group label: Inhaled placebo + oral ondansetron

Other name: Inhaled placebo

Intervention type: Drug

Intervention name: Oral placebo

Description: 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

Arm group label: Inhaled ISO + oral placebo

Other name: Oral sugar water

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Michael D April, MD, PhD, MSc Principal Investigator Brooke Army Medical Center
Location
facility
San Antonio Military Medical Center
Location Countries

United States

Verification Date

November 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Brooke Army Medical Center

Investigator full name: Michael D. April

Investigator title: Assistant Program Director for Research

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Inhaled ISO + oral ondansetron

Arm group type: Active Comparator

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

Arm group label: Inhaled ISO + oral placebo

Arm group type: Experimental

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

Arm group label: Inhaled placebo + oral ondansetron

Arm group type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov