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Haloperidol for the Treatment of Nausea and Vomiting in the ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764344
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Jessica McCoy, Western Michigan University School of Medicine

Study Description
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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
Vomiting Nausea Abdominal Pain Cannabis Use Drug: Haloperidol Drug: Ondansetron Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (time 0) ]
    Marijuanna use will be documented and quantified

  3. QT prolongation [ Time Frame: Baseline (time 0) and 90 minutes ]
    QT will be measured on the cardiac monitor

  4. Incidence of side-effects [ Time Frame: 0, 30, 60, 90 minutes and 24 hours ]
    Inquiry about side effects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764344


Contacts
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Contact: Jessica McCoy, MD 2693376600 jessica.mccoy@med.wmich.edu
Contact: Brenton Kinker, MD 2693376600 brenton.kinker@med.wmich.edu

Locations
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United States, Michigan
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Contact: Jessica McCoy, MD    269-337-6600    jessica.mccoy@med.wmich.edu   
Contact: Pamela Ferris, RN    2693416662    ferrisp@bronsonhg.org   
Sponsors and Collaborators
Western Michigan University School of Medicine
Investigators
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Principal Investigator: Jessica McCoy, MD Western Michigan University School of Medicine
  Study Documents (Full-Text)

Documents provided by Jessica McCoy, Western Michigan University School of Medicine:
Informed Consent Form  [PDF] February 4, 2021

More Information
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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: February 21, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021

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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:
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Nausea
Vomiting
Abdominal Pain
Signs and Symptoms, Digestive
Pain
Neurologic Manifestations
Haloperidol
Ondansetron
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents