VomitingPhase 4NCT04764344
Haloperidol for the Treatment of Nausea and Vomiting in the ED
A Phase 4 study testing Haloperidol and Ondansetron in people with Vomiting and Nausea, run by Western Michigan University School of Medicine at 1 site in United States.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Vomiting, Nausea, Abdominal Pain
- What is being tested?
- Haloperidol and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 22 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- presenting to the emergency department with chief complaint of nausea or vomiting
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
About this study
Official title: A Single Center, Randomized Controlled Prospective Double-blinded Trial Comparing Haloperidol to Standard Ondansetron Therapy for Control of Nausea and Vomiting in the Emergency Department
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.
- Conditions
- Vomiting, Nausea, Abdominal Pain, Cannabis Use
- Being tested
- Haloperidol, Ondansetron
- Medical subject headings
- Vomiting, Nausea, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called Haldol
2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP
OndansetronDrug
Ondansetron
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol | Experimental | 2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride Receives: Drug: Haloperidol |
| Ondansetron | Active comparator | 4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Mean change in visual analog scale (VAS) of self-rated nausea severity
Measured: from enrollment to 30, 60, and 90 minutes after drug administration
Secondary outcomes (4)
Analgesia
Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS)
Measured: 0, 30, 60, 90 minutes
Efficacy in marijuana users
Marijuanna use will be documented and quantified
Measured: Baseline (time 0)
QT prolongation
QT will be measured on the cardiac monitor
Measured: Baseline (time 0) and 90 minutes
Incidence of side-effects
Inquiry about side effects
Measured: 0, 30, 60, 90 minutes and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Apr 2021
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica J McCoy, MD FACEP, Western Michigan University School of Medicine
- Investigators
- Jessica McCoy, MD, Principal investigator, Western Michigan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764344
- Sponsor's protocol ID
- WMed-2020-0690
- Status last verified
- May 2023
- First submitted
- 18 Feb 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized Controlled Prospective Double-blinded Trial Comparing Haloperidol to Standard Ondansetron Therapy for Control of Nausea and Vomiting in the Emergency Department
- ClinicalTrials.gov ID
- NCT04764344
- Acronym / sponsor ID
- WMed-2020-0690
- Conditions
- Vomiting, Nausea, Abdominal Pain, Cannabis Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Western Michigan University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Haloperidol | Experimental | Drug: Haloperidol2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride |
| Ondansetron | Active comparator | Drug: Ondansetron4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- presenting to the emergency department with chief complaint of nausea or vomiting
Key exclusion criteria (12 listed)
- abnormal blood pressure (>200/100mmHg or <90/40mmHg),
- fever (>100.4F),
- acute trauma,
- QT > 450ms on cardiac monitor,
- altered mental status (GCS < 15),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolAlso: Haldol2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP | Drug | Haloperidol |
| OndansetronOndansetron | Drug | Ondansetron |
Primary outcome
Visual Analog Scale (VAS)
Time frame: from enrollment to 30, 60, and 90 minutes after drug administration
Mean change in visual analog scale (VAS) of self-rated nausea severity
4 secondary outcomes
Analgesia
Time frame: 0, 30, 60, 90 minutes
Efficacy in marijuana users
Time frame: Baseline (time 0)
QT prolongation
Time frame: Baseline (time 0) and 90 minutes
Incidence of side-effects
Time frame: 0, 30, 60, 90 minutes and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica McCoy, MD principal investigator
Western Michigan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haloperidol and Ondansetron in people with Vomiting and Nausea, run by Western Michigan University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: from enrollment to 30, 60, and 90 minutes after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.