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Haloperidol for the Treatment of Nausea and Vomiting in the ED

Primary Purpose

Vomiting, Nausea, Abdominal Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Haloperidol
Ondansetron
Sponsored by
Western Michigan University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presenting to the emergency department with chief complaint of nausea or vomiting

Exclusion Criteria:

  • abnormal blood pressure (>200/100mmHg or <90/40mmHg),
  • fever (>100.4F),
  • acute trauma,
  • QT > 450ms on cardiac monitor,
  • altered mental status (GCS < 15),
  • chest pain,
  • known allergy to haloperidol or ondansetron,
  • Parkinson's disease,
  • pregnancy or lactation,
  • use of any antiemetic in the previous 8 hours,
  • nausea and vomiting associated with vertigo,
  • prisoners or any wards of the state.

Sites / Locations

  • Bronson Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Haloperidol

Ondansetron

Arm Description

2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride

4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
Mean change in visual analog scale (VAS) of self-rated nausea severity

Secondary Outcome Measures

Analgesia
Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS)
Efficacy in marijuana users
Marijuanna use will be documented and quantified
QT prolongation
QT will be measured on the cardiac monitor
Incidence of side-effects
Inquiry about side effects

Full Information

First Posted
February 18, 2021
Last Updated
May 31, 2023
Sponsor
Western Michigan University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04764344
Brief Title
Haloperidol for the Treatment of Nausea and Vomiting in the ED
Official Title
A Single Center, Randomized Controlled Prospective Double-blinded Trial Comparing Haloperidol to Standard Ondansetron Therapy for Control of Nausea and Vomiting in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
May 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Michigan University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Nausea, Abdominal Pain, Cannabis Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ondansetron for the treatment of nausea and vomiting.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 150 participants to evaluate for effectiveness and power
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haloperidol
Arm Type
Experimental
Arm Description
2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride
Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Description
2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Ondansetron
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Mean change in visual analog scale (VAS) of self-rated nausea severity
Time Frame
from enrollment to 30, 60, and 90 minutes after drug administration
Secondary Outcome Measure Information:
Title
Analgesia
Description
Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS)
Time Frame
0, 30, 60, 90 minutes
Title
Efficacy in marijuana users
Description
Marijuanna use will be documented and quantified
Time Frame
Baseline (time 0)
Title
QT prolongation
Description
QT will be measured on the cardiac monitor
Time Frame
Baseline (time 0) and 90 minutes
Title
Incidence of side-effects
Description
Inquiry about side effects
Time Frame
0, 30, 60, 90 minutes and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presenting to the emergency department with chief complaint of nausea or vomiting Exclusion Criteria: abnormal blood pressure (>200/100mmHg or <90/40mmHg), fever (>100.4F), acute trauma, QT > 450ms on cardiac monitor, altered mental status (GCS < 15), chest pain, known allergy to haloperidol or ondansetron, Parkinson's disease, pregnancy or lactation, use of any antiemetic in the previous 8 hours, nausea and vomiting associated with vertigo, prisoners or any wards of the state.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica McCoy, MD
Organizational Affiliation
Western Michigan University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States

12. IPD Sharing Statement

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Haloperidol for the Treatment of Nausea and Vomiting in the ED

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