Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

November 22, 2023 updated by: Spectrum Health - Lakeland

A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome

The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult patients with clinical diagnosis of cyclic vomiting in the ED

Exclusion Criteria:

  • pregnancy, allergy to any of the study medicines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: haloperidol
these patients will receive 5mg IM haloperidol
Drug: Haloperidol
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
Active Comparator: droperidol
these patients will receive 2.5mg IV droperidol
Drug: Droperidol
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
Active Comparator: ondansetron
these patients will receive 8mg IV ondansetron
Drug: Ondansetron 8mg
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abdominal pain
Time Frame: 2, 24, 48 hours
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
2, 24, 48 hours
nausea
Time Frame: 2, 24, 48 hours
change in nausea on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
2, 24, 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: 2, 24, 48 hours
both abdominal pain and nausea scores under 2 (none or minimal)
2, 24, 48 hours
Discharge in 2 hours
Time Frame: 2 hours
Percentage of patients with discharge orders placed within 2 hours of treatment initiation
2 hours
Rescue anti-emetics in Emergency Department (ED)
Time Frame: discharge from ED or 12 hours
time interval to need for further anti-emetics in ED
discharge from ED or 12 hours
Rescue narcotics in ED
Time Frame: discharge from ED or 12 hours
time interval to need for narcotics in ED
discharge from ED or 12 hours
Returned to ED
Time Frame: 7 days
percentage of patients with unscheduled return visits to ED within 7 days
7 days
Prolonged ED length of stay over 4 hours
Time Frame: at discharge from ED
total ED length of stay
at discharge from ED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health - Lakeland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 20, 2023

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGME#02-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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