Haloperidol for the Treatment of Nausea and Vomiting in the ED

NCT04764344 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: WMed-2020-0690
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vomiting; Nausea; Abdominal Pain; Cannabis Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analgesia

  0, 30, 60, 90 minutes

• Efficacy in marijuana users

  Baseline (time 0)

• QT prolongation

  Baseline (time 0) and 90 minutes

• Incidence of side-effects

  0, 30, 60, 90 minutes and 24 hours

Study Arms (2)

Haloperidol

EXPERIMENTAL

2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride

Drug: Haloperidol

Ondansetron

ACTIVE COMPARATOR

4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride

Drug: Ondansetron

Interventions

Haloperidol DRUG

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

Also known as: Haldol

Haloperidol

Ondansetron DRUG

Ondansetron

Ondansetron

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• presenting to the emergency department with chief complaint of nausea or vomiting

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Michigan University School of Medicine: lead

Study Sites (1)

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Vomiting; Nausea; Abdominal Pain

Interventions

Haloperidol; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Jessica McCoy, MD

  Western Michigan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 150 participants to evaluate for effectiveness and power
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

US (1)