Haloperidol for the Treatment of Nausea and Vomiting in the ED

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nausea, Vomiting, Abdominal Pain, Cannabis Use

Intervention / Treatment
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* Drug: Haloperidol
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Haloperidol<br>2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride | Drug: Haloperidol<br>* 2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP<br>* Other names: Haldol;|
| Active Comparator: Ondansetron<br>4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride | Drug: Ondansetron<br>* Ondansetron<br>|

What is the study measuring?
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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 |