Haloperidol for the Treatment of Nausea and Vomiting in the ED

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-05-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Vomiting Nausea Abdominal Pain Cannabis Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

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Haloperidol

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

Group Type EXPERIMENTAL

Haloperidol

Intervention Type DRUG

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

Ondansetron

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

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

Ondansetron

Interventions

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Haloperidol

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

Intervention Type DRUG

Ondansetron

Intervention Type DRUG

Other Intervention Names

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Haldol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No