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Inhaled Isopropyl Alcohol for Treatment of Nausea

Primary Purpose

Vomiting, Nausea, Children, Only

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled Isopropyl Alcohol
Oral Ondansetron
Inhaled Placebo
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with a chief complaint of nausea or vomiting
  • Ages 7-178 years, both sexes
  • Weight ≥ 15 kg
  • Baxter Animated Retching Faces (BARF) nausea severity score ≥ 4/10

Exclusion Criteria:

  • 1. Require IV access
  • Inability to breathe in/out through the nose
  • Anosmia (self- or parental report)
  • Allergy to isopropyl alcohol or ondansetron
  • Current or history of alcohol abuse
  • Inability to communicate feeling nauseous
  • Inability to follow directions regarding taking deep breaths through the nose
  • Known prolonged QT interval
  • Pregnancy
  • Received antiemetics within the last 8 hours
  • Currently taking apomorphine

Sites / Locations

  • Oishei Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Inhaled Isopropyl Alcohol

Oral Ondansetron

Inhaled Placebo

Arm Description

If the subject is assigned to receive the isopropyl alcohol pad group, an isopropyl alcohol pad (Covidien Webcol 2 ply prep pad, saturated with 70% isopropyl alcohol) will be given to the subject, or the legal guardian. The alcohol pad will be held 1-2 cm under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed during the Emergency Department (ED) stay.

If the subject is assigned to receive ondansetron treatment, subject will be provided with 4 mg ondansetron oral disintegrating tablet (ODT) for treatment.

If the subject is assigned to receive the inhaled placebo, a normal saline pad (Hygea sterile saline wipe) will be given to the subject or the legal guardian. The saline wipe will be held under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed.

Outcomes

Primary Outcome Measures

Change in Nausea Score at 30 Minutes
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
Change in Nausea Score at 10 Minutes
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
Change in Nausea Score at Discharge
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea

Secondary Outcome Measures

Vomiting
Number of episodes of vomiting post-intervention
Parent/Caregiver Satisfaction
Patient's parent/caregiver satisfaction score (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)
Nurse Satisfaction in Ease of Administering the Treatment
Patient's bedside nurse satisfaction score (very difficult, somewhat difficult, neutral, somewhat easy, very easy)
Length of Stay
Length of patient's stay in the emergency department

Full Information

First Posted
June 1, 2022
Last Updated
September 19, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT05418244
Brief Title
Inhaled Isopropyl Alcohol for Treatment of Nausea
Official Title
Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department: A Open Label, Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To determine the efficacy of inhaled isopropyl alcohol in treating nausea/vomiting among pediatric patients compared with the conventional ondansetron, or placebo treatment in a tertiary care pediatric emergency department.
Detailed Description
I. Obtaining consent Our study personnel will approach the treating physician in the ED once a patient is suspected to be eligible for the study. The physician will determine patient's eligibility by using the screening sheet. If a patient meets all study inclusion and exclusion criteria, our study personnel will approach the legal guardian/patient in the private patient room and introduce the study to them. Enough time will be given to the patient and their legal guardian to allow them review and understand the consent/assent. All questions will be answered before obtaining the consent. Once the consent/assent is obtained from the legal guardian and participant, our study personnel will keep the treating physician and bedside nurse posted about the enrollment. II. Randomization of subject There will be three arms of this study: Conventional oral ondansetron (Zofran) treatment group, Inhaled isopropyl alcohol treatment group, Inhaled normal saline (placebo) group. After obtaining informed consent, the patients will be randomized into one of the three groups following a randomization table created by a statistician. Whichever intervention is randomly selected will be used to treat the subject. Our research team member will notify the treating physician and the bedside RN about the assignment. If the subject is assigned to receive ondansetron treatment, subject will be provided with 4 mg ondansetron oral disintegrating tablet (ODT) for treatment. If the subject is assigned to receive the isopropyl alcohol pad group, an isopropyl alcohol pad (Covidien Webcol 2 ply prep pads, saturated with 70% isopropyl alcohol) will be given to the subject, or the legal guardian . The alcohol pad will be held 1-2 cm under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed during the ED stay. If the subject is assigned to receive the inhaled placebo, a normal saline pad (Hygea sterile saline wipe) will be given to the subject or the legal guardian. The saline wipe will be held under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed. For those subject who receives normal saline or alcohol pad treatment, if their vomit/nausea symptoms has not improvement after 30 minutes post intervention, they may receive Zofran treatment in the ED. III. Data collection A paper data collection form will be used to collect data in the ED, which is attached with this submission. Patient ID sticker with name, MRN, FIN, and DOB will be placed on the data form. This data form will be completed by the ED research assistant. The completed data form as well as the signed informed consent document will be placed in a locked study data box in the ED. The study coordinator will collect these documents from the ED periodically, and transfer the documents to the UBMD Pediatrics Department Research Office (5th Floor Conventus, 1001 Main St, Buffalo, NY 14203). All paper documents will be stored in locked file cabinet in the office. Two databases will be created for this study, the Subject Database and the PHI database. Subject identifiable information will be entered in the PHI database, which include: MRN, FIN, and DOB. All other data elements will be entered in the Subject Database. Certain PHI e.g. ED visit/discharge date, study intervention administration date will also be entered in the Subject database for the convenience of data analysis. A unique study ID will be assigned to each subject, this ID number will be used as the code key to link the paper data form, Subject Database and PHI database. Both databases will be saved in study coordinator's password protected UPA online drive, the PHI database will be double secured by a code. Data Collection: Demographic data: Patient age, sex, race, and ethnicity Baxter Animated Retching Faces nausea score at: Baseline (prior to intervention), 10 minutes post-intervention, 30 minutes post-intervention, and at ED discharge. The 10 minute post-intervention timepoint was selected because prior research in adult post-operative patients has shown that inhaled isopropyl alcohol significantly improved nausea on surveys conducted 5, 10, and 15 minute after inhalation.6 The 30 minute post-intervention timepoint was selected because the onset of action for ondansetron oral disintegrated tablet is within 30 minutes.132 We will reassess nausea symptoms at ED discharge to account for any anti-emetic benefit that may have only be transient. ED clinical information about vomiting and apparent aspiration Patient/caregiver perceived side effects of treatment Satisfaction scores: From both the bedside nurse and the patient's caregiver Cross-over information: Did the patient use a treatment other than the assigned treatment (e.g. if the patient was in the inhaled isopropyl alcohol group, did they cross-over into the ondansetron ODT group) ED discharge information: Length of stay, patient disposition and discharge diagnosis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Nausea, Children, Only

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Isopropyl Alcohol
Arm Type
Experimental
Arm Description
If the subject is assigned to receive the isopropyl alcohol pad group, an isopropyl alcohol pad (Covidien Webcol 2 ply prep pad, saturated with 70% isopropyl alcohol) will be given to the subject, or the legal guardian. The alcohol pad will be held 1-2 cm under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed during the Emergency Department (ED) stay.
Arm Title
Oral Ondansetron
Arm Type
Active Comparator
Arm Description
If the subject is assigned to receive ondansetron treatment, subject will be provided with 4 mg ondansetron oral disintegrating tablet (ODT) for treatment.
Arm Title
Inhaled Placebo
Arm Type
Placebo Comparator
Arm Description
If the subject is assigned to receive the inhaled placebo, a normal saline pad (Hygea sterile saline wipe) will be given to the subject or the legal guardian. The saline wipe will be held under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed.
Intervention Type
Other
Intervention Name(s)
Inhaled Isopropyl Alcohol
Other Intervention Name(s)
Webcol
Intervention Description
Isopropyl alcohol pad (Covidien Webcol 2 ply prep pads, saturated with 70% isopropyl alcohol) held 1-2 cm under the subject's nares
Intervention Type
Drug
Intervention Name(s)
Oral Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
4 mg oral disintegrating ondansetron tablet once
Intervention Type
Other
Intervention Name(s)
Inhaled Placebo
Other Intervention Name(s)
Inhaled Normal Saline'
Intervention Description
Normal saline pad (Hygea sterile saline wipe) held 1-2 cm under the subject's nares
Primary Outcome Measure Information:
Title
Change in Nausea Score at 30 Minutes
Description
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
Time Frame
30 minutes post-intervention as compared to baseline
Title
Change in Nausea Score at 10 Minutes
Description
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
Time Frame
10 minutes post-interventnon as compared to baseline
Title
Change in Nausea Score at Discharge
Description
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
Time Frame
At ED discharge (assessed up to 10 hours) as compared to baseline
Secondary Outcome Measure Information:
Title
Vomiting
Description
Number of episodes of vomiting post-intervention
Time Frame
From intervention to time of ED discharge (assessed up to 10 hours)
Title
Parent/Caregiver Satisfaction
Description
Patient's parent/caregiver satisfaction score (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)
Time Frame
At time of ED discharge (assessed up to 10 hours)
Title
Nurse Satisfaction in Ease of Administering the Treatment
Description
Patient's bedside nurse satisfaction score (very difficult, somewhat difficult, neutral, somewhat easy, very easy)
Time Frame
At time of ED discharge (assessed up to 10 hours)
Title
Length of Stay
Description
Length of patient's stay in the emergency department
Time Frame
From arrival to time of ED discharge (assessed up to 10 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with a chief complaint of nausea or vomiting Ages 7-178 years, both sexes Weight ≥ 15 kg Baxter Animated Retching Faces (BARF) nausea severity score ≥ 4/10 Exclusion Criteria: 1. Require IV access Inability to breathe in/out through the nose Anosmia (self- or parental report) Allergy to isopropyl alcohol or ondansetron Current or history of alcohol abuse Inability to communicate feeling nauseous Inability to follow directions regarding taking deep breaths through the nose Known prolonged QT interval Pregnancy Received antiemetics within the last 8 hours Currently taking apomorphine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiping Qiao, MBBS, MS
Phone
7163230055
Email
hqiao@upa.chob.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alana Koehler, MD
Phone
315576264
Email
alanakoe@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana Koehler, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heather Territo, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Study Director
Facility Information:
Facility Name
Oishei Children's Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiping Qiao
Phone
716-323-0055
Email
hqiao@upa.chob.edu

12. IPD Sharing Statement

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Inhaled Isopropyl Alcohol for Treatment of Nausea

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