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Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05065567
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Spectrum Health - Lakeland

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.

Condition or disease Intervention/treatment Phase
Cyclic Vomiting Syndrome Drug: Droperidol Drug: Haloperidol Drug: Ondansetron 8mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : September 2023


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




Primary Outcome Measures :
  1. 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. nausea [ Time Frame: 2, 24, 48 hours ]
    change in nausea on 0 (no pain) through 10 (worse possible pain) on a visual analog scale


Secondary Outcome Measures :
  1. Treatment success [ Time Frame: 2, 24, 48 hours ]
    both abdominal pain and nausea scores under 2 (none or minimal)

  2. Discharge in 2 hours [ Time Frame: 2 hours ]
    Percentage of patients with discharge orders placed within 2 hours of treatment initiation

  3. 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

  4. Rescue narcotics in ED [ Time Frame: discharge from ED or 12 hours ]
    time interval to need for narcotics in ED

  5. Returned to ED [ Time Frame: 7 days ]
    percentage of patients with unscheduled return visits to ED within 7 days

  6. Prolonged ED length of stay over 4 hours [ Time Frame: at discharge from ED ]
    total ED length of stay



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy, allergy to any of the study medicines

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065567


Locations
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United States, Michigan
Lakeland Regional Healthcare Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Michelino Mancini, DO, FAOECP    269-983-4081    mmancini@lakelandhealth.org   
Sponsors and Collaborators
Spectrum Health - Lakeland
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Responsible Party: Spectrum Health - Lakeland
ClinicalTrials.gov Identifier: NCT05065567    
Other Study ID Numbers: EGME#02-2021
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Syndrome
Vomiting
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Morning Sickness
Pregnancy Complications
Droperidol
Haloperidol
Ondansetron
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Dopamine Antagonists
Dopamine Agents