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Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

Primary Purpose

Cyclic Vomiting Syndrome

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Droperidol
Haloperidol
Ondansetron 8mg
Sponsored by
Spectrum Health - Lakeland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cyclic Vomiting Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy, allergy to any of the study medicines

Sites / Locations

  • Lakeland Regional HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

haloperidol

droperidol

ondansetron

Arm Description

these patients will receive 5mg IM haloperidol

these patients will receive 2.5mg IV droperidol

these patients will receive 8mg IV ondansetron

Outcomes

Primary Outcome Measures

abdominal pain
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
nausea
change in nausea on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2021
Last Updated
October 25, 2022
Sponsor
Spectrum Health - Lakeland
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1. Study Identification

Unique Protocol Identification Number
NCT05065567
Brief Title
Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis
Official Title
A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health - Lakeland

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclic Vomiting Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
haloperidol
Arm Type
Active Comparator
Arm Description
these patients will receive 5mg IM haloperidol
Arm Title
droperidol
Arm Type
Active Comparator
Arm Description
these patients will receive 2.5mg IV droperidol
Arm Title
ondansetron
Arm Type
Active Comparator
Arm Description
these patients will receive 8mg IV ondansetron
Intervention Type
Drug
Intervention Name(s)
Droperidol
Intervention Description
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
Intervention Type
Drug
Intervention Name(s)
Ondansetron 8mg
Intervention Description
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron
Primary Outcome Measure Information:
Title
abdominal pain
Description
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Time Frame
2, 24, 48 hours
Title
nausea
Description
change in nausea on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Time Frame
2, 24, 48 hours
Secondary Outcome Measure Information:
Title
Treatment success
Description
both abdominal pain and nausea scores under 2 (none or minimal)
Time Frame
2, 24, 48 hours
Title
Discharge in 2 hours
Description
Percentage of patients with discharge orders placed within 2 hours of treatment initiation
Time Frame
2 hours
Title
Rescue anti-emetics in Emergency Department (ED)
Description
time interval to need for further anti-emetics in ED
Time Frame
discharge from ED or 12 hours
Title
Rescue narcotics in ED
Description
time interval to need for narcotics in ED
Time Frame
discharge from ED or 12 hours
Title
Returned to ED
Description
percentage of patients with unscheduled return visits to ED within 7 days
Time Frame
7 days
Title
Prolonged ED length of stay over 4 hours
Description
total ED length of stay
Time Frame
at discharge from ED

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients with clinical diagnosis of cyclic vomiting in the ED Exclusion Criteria: pregnancy, allergy to any of the study medicines
Facility Information:
Facility Name
Lakeland Regional Healthcare
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelino Mancini, DO, FAOECP
Phone
269-983-4081
Email
mmancini@lakelandhealth.org

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

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