Haloperidol for the Treatment of Nausea and Vomiting in the ED

Western Michigan University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Vomiting; Nausea; Cannabis Use; Abdominal Pain

Treatments: Drug: Haloperidol; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT04764344

WMed-2020-0690

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Haloperidol

Experimental group

Description:

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

Treatment:

Drug: Haloperidol

Ondansetron

Active Comparator group

Description:

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

Treatment:

Drug: Ondansetron