Haloperidol for the Treatment of Nausea and Vomiting in the ED

Western Michigan University School of Medicine60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Vomiting Nausea Abdominal Pain Cannabis Use

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Analgesia

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

Time frame: 0, 30, 60, 90 minutes

Efficacy in marijuana users

Marijuanna use will be documented and quantified

Time frame: Baseline (time 0)

QT prolongation

QT will be measured on the cardiac monitor

Time frame: Baseline (time 0) and 90 minutes

Incidence of side-effects

Inquiry about side effects

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