Haloperidol vs Conventional Therapy for Gastroparesis

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.

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