Haloperidol for the Treatment of Nausea and Vomiting in t... | NCT04764344

Studies
Haloperidol for the Treatment of Nausea and Vomiting in the ED

NCT04764344

Sponsor

Western Michigan University School of Medicine

Status

Completed

Last Update Posted

Jun 1, 2023Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Vomiting
Nausea
Abdominal Pain
Cannabis Use

Interventions

Haloperidol
Ondansetron

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

May 22, 2023Actual

Completion Date

May 22, 2023Actual

First Submitted Date

Feb 18, 2021

First Submission Date that Met QC Criteria

Feb 19, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2023

Last Update Posted Date

Jun 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jessica J McCoy, MD FACEP, Clinical Associate Professor, Western Michigan University School of MedicinePrincipal Investigator

Lead Sponsor

Western Michigan University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Haloperidol	Experimental	2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride	Drug: Haloperidol
Ondansetron	Active Comparator	4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride	Drug: Ondansetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haloperidol	Drug	2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP	Haloperidol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scale (VAS)	Mean change in visual analog scale (VAS) of self-rated nausea severity	from enrollment to 30, 60, and 90 minutes after drug administration

Secondary Outcomes

Measure	Description	Time Frame
Analgesia	Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS)	0, 30, 60, 90 minutes
Efficacy in marijuana users	Marijuanna use will be documented and quantified

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

presenting to the emergency department with chief complaint of nausea or vomiting

Exclusion Criteria:

abnormal blood pressure (>200/100mmHg or <90/40mmHg),
fever (>100.4F),
acute trauma,
QT > 450ms on cardiac monitor,
altered mental status (GCS < 15),
chest pain,
known allergy to haloperidol or ondansetron,
Parkinson's disease,
pregnancy or lactation,
use of any antiemetic in the previous 8 hours,
nausea and vomiting associated with vertigo,
prisoners or any wards of the state.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jessica McCoy, MD	Western Michigan University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bronson Methodist Hospital		Kalamazoo	Michigan	49007	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Feb 4, 2021	Feb 22, 2021	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D014839	Vomiting
D009325	Nausea
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006220	Haloperidol
D017294	Ondansetron

Ancestor Terms

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ondansetron for the treatment of nausea and vomiting.

Masking Info

Masking

Triple

Masking Description

Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 150 participants to evaluate for effectiveness and power

Who Masked

ParticipantCare ProviderInvestigator