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Haloperidol for the Treatment of Nausea and Vomiting in the ED

Sponsor
Western Michigan University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04764344
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
10.1
Anticipated Duration (Months)
29.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Triple (Participant, Care Provider, Investigator)
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
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Haloperidol

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

Drug: Haloperidol
2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP
Other Names:
  • Haldol

    		•
    Active Comparator: Ondansetron

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

    Drug: Ondansetron
    Ondansetron

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Scale (VAS) [from enrollment to 30, 60, and 90 minutes after drug administration]

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

    Secondary Outcome Measures

    1. Analgesia [0, 30, 60, 90 minutes]

      Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS)

    2. Efficacy in marijuana users [Baseline (time 0)]

      Marijuanna use will be documented and quantified

    3. QT prolongation [Baseline (time 0) and 90 minutes]

      QT will be measured on the cardiac monitor

    4. Incidence of side-effects [0, 30, 60, 90 minutes and 24 hours]

      Inquiry about side effects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bronson Methodist Hospital Kalamazoo Michigan United States 49007

    Sponsors and Collaborators

    • Western Michigan University School of Medicine

    Investigators

    • Principal Investigator: Jessica McCoy, MD, Western Michigan University School of Medicine

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Jessica McCoy, Clinical Associate Professor, Western Michigan University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04764344
    Other Study ID Numbers:
    • WMed-2020-0690
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Feb 1, 2021
    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
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Abdominal Pain
    Haloperidol
    Ondansetron
    Haloperidol decanoate

    Study Results

    No Results Posted as of Feb 25, 2021