Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

• Sponsor: Spectrum Health - Lakeland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05065567
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cyclic Vomiting Syndrome	Drug: Droperidol; Drug: Haloperidol; Drug: Ondansetron 8mg	Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 30, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. abdominal pain [2, 24, 48 hours]

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

2. nausea [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 [2, 24, 48 hours]

   both abdominal pain and nausea scores under 2 (none or minimal)

2. Discharge in 2 hours [2 hours]

   Percentage of patients with discharge orders placed within 2 hours of treatment initiation

3. Rescue anti-emetics in Emergency Department (ED) [discharge from ED or 12 hours]

   time interval to need for further anti-emetics in ED

4. Rescue narcotics in ED [discharge from ED or 12 hours]

   time interval to need for narcotics in ED

5. Returned to ED [7 days]

   percentage of patients with unscheduled return visits to ED within 7 days

6. Prolonged ED length of stay over 4 hours [at discharge from ED]

   total ED length of stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy, allergy to any of the study medicines

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lakeland Regional Healthcare	Saint Joseph	Michigan	United States	49085

Sponsors and Collaborators

• Spectrum Health - Lakeland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spectrum Health - Lakeland
• ClinicalTrials.gov Identifier: NCT05065567
• Other Study ID Numbers: EGME#02-2021
• First Posted: Oct 4, 2021
• Last Update Posted: May 13, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Hyperemesis Gravidarum; Syndrome; Vomiting; Droperidol; Haloperidol; Ondansetron; Haloperidol decanoate

Study Results

No Results Posted as of May 13, 2022