Haloperidol for the Treatment of Nausea and Vomiting in the ED

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764344
• Other study ID #: WMed-2020-0690
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: May 22, 2023

Study information

• Verified date: May 2023
• Source: Western Michigan University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Cannabis Use
• Nausea
• Vomiting

Intervention

Drug:
• Haloperidol
2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP
• Ondansetron
Ondansetron

Locations

Country	Name	City	State
United States	Bronson Methodist Hospital	Kalamazoo	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Western Michigan University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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