Haloperidol for the Treatment of Nausea and Vomiting in the ED

Phase 4

Completed

• Conditions: Vomiting; Nausea; Abdominal Pain; Cannabis Use
• Interventions: Drug: Haloperidol; Drug: Ondansetron

• Registration Number: NCT04764344
• Lead Sponsor: Western Michigan University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Study Start: 2021-04-01
• Status Verified: 2023-05
• Primary Completion: 2023-05-22
• Study Completion: 2023-05-22
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haloperidol	Haloperidol	2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride
Ondansetron	Ondansetron	4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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

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

Trial Locations

Locations (1)

Bronson Methodist Hospital; 🇺🇸 Kalamazoo, Michigan, United States