Haloperidol for the Treatment of Nausea and Vomiting in the ED

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

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.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Abdominal Pain; Cannabis Use
• Intervention / Treatment: Drug: Haloperidol; Drug: Ondansetron

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica McCoy, MD; Phone Number: 2693376600; Email: jessica.mccoy@med.wmich.edu
• Study Contact Backup: Name: Brenton Kinker, MD; Phone Number: 2693376600; Email: brenton.kinker@med.wmich.edu

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
      • Contact: Jessica McCoy, MD; Phone Number: 269-337-6600; Email: jessica.mccoy@med.wmich.edu
      • Contact: Pamela Ferris, RN; Phone Number: 2693416662; Email: ferrisp@bronsonhg.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Mean change in visual analog scale (VAS) of self-rated nausea severity	from enrollment to 30, 60, and 90 minutes after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia	Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS)	0, 30, 60, 90 minutes
Efficacy in marijuana users	Marijuanna use will be documented and quantified	Baseline (time 0)
QT prolongation	QT will be measured on the cardiac monitor	Baseline (time 0) and 90 minutes
Incidence of side-effects	Inquiry about side effects	0, 30, 60, 90 minutes and 24 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Nausea; Vomiting; Abdominal Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Anti-Dyskinesia Agents; Haloperidol; Haloperidol decanoate; Ondansetron
• Other Study ID Numbers: WMed-2020-0690

Drug and device information, study documents

• 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