Haloperidol vs Conventional Therapy for Gastroparesis

Study Overview
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Brief Summary
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Randomized controlled trial comparing haloperidol combined with conventional therapy and conventional therapy alone in patients with symptomatic gastroparesis.

Detailed Description
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Study Design This study is a prospective, double-blind randomized placebo controlled trial involving adult emergency department (ED) patients who present with an acute exacerbation of gastroparesis. This study design will have two arms in the clinical trials. An experimental arm will receive an intravenous dose of haloperidol 5 mg in addition to conventional therapy, and the control arm will receive conventional therapy. Patients will be randomized as described below. Neither the physician nor the patient will be aware of the group to which the patient was randomized. Methods Upon arrive at to the ED at the Memorial Hermann Hospital located in the Texas Medical Center; patients with gastroparesis (GP) exacerbation will be assessed for eligibility for enrollment in this trial by the clinicians on duty. Informed consent will be obtained from eligible patients that meet inclusion and exclusion criteria by trained ED residents. A 12 lead electrocardiogram will be performed to evaluate the presence of QT segment prolongation. Enrolled patients will be given 5 mg of intravenous haloperidol or equivalent volume of placebo pre-packaged and coded with a study ID number provided by the investigational pharmacy. No unique identifiers or other PHI will be collected on enrolled patients. Information will also be recorded on the time elapsed from the time it took to provide the study medication and the time of the decision on disposition (admit or discharge). A record will be maintained if any additional medications including analgesics and antiemetics given to the patient before and after the study vial are given. Data will be collected on any adverse effects or complications the patients may experience (i.e. dystonic reactions, allergies etc.). After the data is collected at one hour for the primary outcome the trial will end and the physician will be unblended so they can choose subsequent medication. All completed data collection forms will be dropped off in a secure locked mailbox and collected on a weekly basis by research staff. Collected forms will be housed in the ED office located in the Jesse Jones Library (JJL) 4th floor in a locked cabinet. Data will be entered electronically and analyzed using statistical package for the social sciences (SPSS) version 19.0. This database will be housed on a rights-protected research drive with limited access for viewing. Informed Consent Patients will be notified of this study and they will be asked if they are interested in participating. If they are interested in participating, they will have the informed consent (IC) explained to them in either English or Spanish (Beaudoin, Nagdev, Merchant & Becker, 2010). The patient will sign, date, and put the time on the IC. The consenter will also do the same. A copy of the IC will be made in the ED and given to the patient for their records. The original copy will be housed in the regulatory binder located in JJL.

Official Title
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Haloperidol vs Conventional Therapy for Gastroparesis

Conditions
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Gastroparesis

Intervention / Treatment
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* Drug: Haloperidol
* Drug: Conventional Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous diagnosis of GP including those without formal gastric emptying studies. Patients presenting with unresolving nausea, vomiting, and abdominal pain that is attributable to their GP. Exclusion Criteria: History of QT prolongation or presence on a 12 leads electrocardiogram. Presence of concomitant acute abdominal pathology including but not limited to hepatobiliary disease, ischemia, and abdominal aneurysm. Prisoners Hypotension (systolic blood pressure below 90 mm Hg) Pregnant women Patients who are cognitively impaired and/or unable to consent for the study Age <18 Allergy to haloperidol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Haloperidol plus Conventional Therapy<br>Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed. | Drug: Haloperidol<br>* Intravenous dose of haloperidol 5 mg.<br>* Other names: Haldol;|
| Active Comparator: Conventional Therapy alone<br>Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed. | Drug: Conventional Therapy<br>* Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication |  | 1 hour after study medication given | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Admitted to the Hospital After Emergency Department Visit |  | 2 hours after study medication given | 
| Emergency Department Length of Stay (EDLOS) | The time frame starts from the moment of receiving the study drug to the time when the decision for final disposition is made. Usually after symptoms are controlled, patients are given a PO challenge (food or drink) in order to establish if they are OK to go home. If symptoms return, additional medications are given, the treatment is consider failed and they are admitted to the Hospital. Patients will not be followed up if admitted to any service. The study ends when final disposition is made. Patients follow up after final disposition is not part of the study and will not be done. | at the time the decision for final disposition is made (about 8 hours) | 
| Pain Score as Measured by a Visual Analogue Scale (VAS) | The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain. | before study medication given | 
| Pain Score as Measured by a Visual Analogue Scale (VAS) | The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain. | 1 hour after study medication given | 
| Nausea Score as Measured by a Visual Analogue Scale (VAS) | The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea. | before study medication given | 
| Nausea Score as Measured by a Visual Analogue Scale (VAS) | The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea. | 1 hour after study medication given | 
| Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication |  | 1 hour after study medication given |