Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

Study Overview
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Brief Summary
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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.

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

Conditions
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Cyclic Vomiting Syndrome

Intervention / Treatment
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* Drug: Droperidol
* Drug: Haloperidol
* Drug: Ondansetron 8mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with clinical diagnosis of cyclic vomiting in the ED Exclusion Criteria: pregnancy, allergy to any of the study medicines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal pain | change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale | 2, 24, 48 hours | 
| nausea | 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 | both abdominal pain and nausea scores under 2 (none or minimal) | 2, 24, 48 hours | 
| Discharge in 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 interval to need for further anti-emetics in ED | discharge from ED or 12 hours | 
| Rescue narcotics in ED | time interval to need for narcotics in ED | discharge from ED or 12 hours | 
| Returned to ED | percentage of patients with unscheduled return visits to ED within 7 days | 7 days | 
| Prolonged ED length of stay over 4 hours | total ED length of stay | at discharge from ED |