Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

Cyclic Vomiting Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05065567
• Other study ID #: EGME#02-2021
• Status: Terminated
• Phase: Phase 2
• Start date: August 30, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: Spectrum Health - Lakeland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy, allergy to any of the study medicines

Related Conditions & MeSH terms

• Cyclic Vomiting Syndrome
• Hyperemesis Gravidarum
• Syndrome
• Vomiting

Intervention

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
• Haloperidol
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
• Ondansetron 8mg
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Locations

Country	Name	City	State
United States	Lakeland Regional Healthcare	Saint Joseph	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health - Lakeland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abdominal pain	change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale	2, 24, 48 hours
Primary	nausea	change in nausea on 0 (no pain) through 10 (worse possible pain) on a visual analog scale	2, 24, 48 hours
Secondary	Treatment success	both abdominal pain and nausea scores under 2 (none or minimal)	2, 24, 48 hours
Secondary	Discharge in 2 hours	Percentage of patients with discharge orders placed within 2 hours of treatment initiation	2 hours
Secondary	Rescue anti-emetics in Emergency Department (ED)	time interval to need for further anti-emetics in ED	discharge from ED or 12 hours
Secondary	Rescue narcotics in ED	time interval to need for narcotics in ED	discharge from ED or 12 hours
Secondary	Returned to ED	percentage of patients with unscheduled return visits to ED within 7 days	7 days
Secondary	Prolonged ED length of stay over 4 hours	total ED length of stay	at discharge from ED