Gastroparesis
Conditions
Brief summary
Randomized controlled trial comparing haloperidol combined with conventional therapy and conventional therapy alone in patients with symptomatic gastroparesis.
Detailed description
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.
Interventions
DRUGHaloperidol
Intravenous dose of haloperidol 5 mg.
DRUGConventional 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication | 1 hour after study medication given |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Admitted to the Hospital After Emergency Department Visit | 2 hours after study medication given | — |
| Emergency Department Length of Stay (EDLOS) | at the time the decision for final disposition is made (about 8 hours) | 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. |
| Pain Score as Measured by a Visual Analogue Scale (VAS) | before study medication given | The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain. |
| Nausea Score as Measured by a Visual Analogue Scale (VAS) | before study medication given | The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea. |
| Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication | 1 hour after study medication given | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Haloperidol Plus Conventional Therapy 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. | 15 |
| 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. | 18 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Haloperidol Plus Conventional Therapy | Conventional Therapy | Total |
|---|---|---|---|
| Age, Continuous | 47 years | 45 years | 46 years |
| Region of Enrollment United States | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 18 |
| other Total, other adverse events | 0 / 15 | 0 / 18 |
| serious Total, serious adverse events | 0 / 15 | 0 / 18 |
Outcome results
Primary
Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication
Time frame: 1 hour after study medication given
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Haloperidol Plus Conventional Therapy | Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication | 11 Participants |
| Conventional Therapy | Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication | 5 Participants |
Secondary
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.
Time frame: at the time the decision for final disposition is made (about 8 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Haloperidol Plus Conventional Therapy | Emergency Department Length of Stay (EDLOS) | 4.8 hours |
| Conventional Therapy | Emergency Department Length of Stay (EDLOS) | 9 hours |
Secondary
Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication
Time frame: 1 hour after study medication given
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Haloperidol Plus Conventional Therapy | Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication | 11 Participants |
| Conventional Therapy | Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication | 13 Participants |
Secondary
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.
Time frame: before study medication given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol Plus Conventional Therapy | Nausea Score as Measured by a Visual Analogue Scale (VAS) | 4.53 units on a scale | Standard Deviation 0.83 |
| Conventional Therapy | Nausea Score as Measured by a Visual Analogue Scale (VAS) | 4.11 units on a scale | Standard Deviation 0.96 |
Secondary
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.
Time frame: 1 hour after study medication given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol Plus Conventional Therapy | Nausea Score as Measured by a Visual Analogue Scale (VAS) | 1.83 units on a scale | Standard Deviation 1.92 |
| Conventional Therapy | Nausea Score as Measured by a Visual Analogue Scale (VAS) | 3.39 units on a scale | Standard Deviation 1.68 |
Secondary
Number of Participants Admitted to the Hospital After Emergency Department Visit
Time frame: 2 hours after study medication given
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Haloperidol Plus Conventional Therapy | Number of Participants Admitted to the Hospital After Emergency Department Visit | 4 Participants |
| Conventional Therapy | Number of Participants Admitted to the Hospital After Emergency Department Visit | 13 Participants |
Secondary
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.
Time frame: before study medication given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol Plus Conventional Therapy | Pain Score as Measured by a Visual Analogue Scale (VAS) | 8.50 units on a scale | Standard Deviation 1.82 |
| Conventional Therapy | Pain Score as Measured by a Visual Analogue Scale (VAS) | 8.28 units on a scale | Standard Deviation 1.77 |
Secondary
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.
Time frame: 1 hour after study medication given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol Plus Conventional Therapy | Pain Score as Measured by a Visual Analogue Scale (VAS) | 3.13 units on a scale | Standard Deviation 3.6 |
| Conventional Therapy | Pain Score as Measured by a Visual Analogue Scale (VAS) | 7.17 units on a scale | Standard Deviation 2.81 |