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CompletedNCT04764344Updated Jun 1, 2023

Haloperidol for the Treatment of Nausea and Vomiting in the ED

A Phase 4 interventional study of Haloperidol and Ondansetron in Vomiting, Nausea and Abdominal Pain, sponsored by Western Michigan University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-06-01.

Sponsored by Western Michigan University School of Medicine · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2023, 3 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

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Conditions studied

  • Vomiting
  • Nausea
  • Abdominal Pain
  • Cannabis Use
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In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 60 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Western Michigan University School of Medicine is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Haloperidol

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

    Drug: Haloperidol

  • Active comparator
    Ondansetron

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

    Drug: Ondansetron

Interventions

  • DrugHaloperidol

    2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP

    Also known as: Haldol

  • DrugOndansetron

    Ondansetron

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What researchers measure

Primary outcomes

  1. Visual Analog Scale (VAS)

    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 outcomes

  1. Analgesia

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

    Time frame: 0, 30, 60, 90 minutes

  2. Efficacy in marijuana users

    Marijuanna use will be documented and quantified

    Time frame: Baseline (time 0)

  3. QT prolongation

    QT will be measured on the cardiac monitor

    Time frame: Baseline (time 0) and 90 minutes

  4. Incidence of side-effects

    Inquiry about side effects

    Time frame: 0, 30, 60, 90 minutes and 24 hours

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Study locations

1 site
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
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References and documents

Study documents

  • Informed consent form · Feb 4, 2021

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04764344
Lead sponsor
Western Michigan University School of Medicine
Responsible party
Jessica J McCoy, MD FACEP (Clinical Associate Professor, Western Michigan University School of Medicine) — Principal investigator
First posted
Feb 21, 2021
Start date
Apr 1, 2021
Primary completion
May 22, 2023
Completion
May 22, 2023
Last update
Jun 1, 2023

Study contacts

Jessica McCoy, MD
principal investigator · Western Michigan University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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