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Completed

NCT Number: NCT04764344

Haloperidol for the Treatment of Nausea and Vomiting in the ED

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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Key information

Conditions

Vomiting Abdominal Pain Cannabis Use Nausea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haloperidol

Drug

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

Other names: Haldol

ondansetron

Drug

Ondansetron

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: from enrollment to 30, 60, and 90 minutes after drug administration

    Mean change in visual analog scale (VAS) of self-rated nausea severity

Secondary outcomes

  1. Analgesia

    Time frame: 0, 30, 60, 90 minutes

    Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS)

  2. Efficacy in marijuana users

    Time frame: Baseline (time 0)

    Marijuanna use will be documented and quantified

  3. QT prolongation

    Time frame: Baseline (time 0) and 90 minutes

    QT will be measured on the cardiac monitor

  4. Incidence of side-effects

    Time frame: 0, 30, 60, 90 minutes and 24 hours

    Inquiry about side effects

Sponsors and collaborators

Lead sponsor

Western Michigan University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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