Cannabinoid Hyperemesis Syndrome
Conditions
Brief summary
The aim of the study is to identify which medication (haloperidol or olanzapine) is most effective in treating nausea and abdominal pain associated with cannabinoid hyperemesis using a 10-point visual analog scale with intervals of 0.5.
Detailed description
Subjects will be weighed, have blood drawn (\ 20 mL, 5 teaspoons) and analyzed (CBC w/diff, CMP, lipase, quantitative hcG (if female)), urinalysis with microscopy if indicated, urine drug screen, and an ECG as part of standard routine care for such complaint in the emergency department. After consent is obtained, subjects will then be asked to rate their baseline nausea and abdominal pain on two separate 10-cm visual analog scales (VASs) \[0-10, 0.5 for minor symptoms, 10 for severe symptoms\]. The subjects will be pre-randomized with a computer program by an unaffiliated person to evenly distribute participants. Envelopes will be prepared by pharmacy staff with the participant number and assigned study drug, Haloperidol 5 mg or Olanzapine 10 mg, to be ready for use when a patient is enrolled. Opaque or otherwise concealed syringes will be used to maintain blinding of the administering nurse. Using a standardized order set within the EMR, subjects will be given the assigned study drug intramuscularly, and the nurse will document CH2O study drug administered in the electronic medical record. The subject will be monitored with five cardiac leads and pulse oximeter after receiving the study drug. While receiving intravenous crystalloid and sips of oral rehydration solution as needed, patients again will score their nausea and abdominal pain 60 minutes after medication administration, using a parallel 10-point VAS with prior score(s) visible. At 60-120 minutes after treatment, the treating physician identifies discharge readiness or, failing that, provides further orders including any rescue antiemetics (ondansetron, prochlorperazine, promethazine, or metoclopramide recommended), fluids, or imaging deemed necessary. Lastly, if appropriate, record to the nearest minute the time the patient was deemed discharge ready. After the patient's ED visit, no further collaboration will be needed from the patient. The ED chart will be reviewed to collect data including ability to tolerate liquids PO at one hour, if abdominal imaging was ordered, time of medication administration to ED discharge, admission status, need for rescue antiemetic or analgesics. The subject's information will not be used or distributed for future research studies Subjects, all physicians, nurses, ED pharmacists, research personnel, and the investigators, including the biostatistician, will be blinded to treatment allocation until the end of the trial. In case of emergency, the unblinding will be permitted.
Interventions
olanzapine 10 mg IM
DRUGHaloperidol
Haloperidol 5 mg IM
Sponsors
Mercy Bon Secours Saint Vincent Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* subjects must meet ONE of the below criteria AND are a near-daily to daily user of cannabis by inhalation for greater than or equal to 6 months. 1. Have documented previous diagnosis of cannabinoid hyperemesis, or 2. Report (or on chart review) greater than or equal to 3 episodes of emesis in a cyclic pattern separated by greater than 1 month during the preceding 2 years, or 3. The provider suspects cannabinoid hyperemesis as the primary or equally likely primary diagnosis.
Exclusion criteria
* Ineligible subjects include age less than 18 years, weight less than 50 kg, pregnancy, daily benzodiazepines use, prolonged QTc interval on the electrocardiogram (ECG), breastfeeding mothers, previously known allergy to or intolerance of either study drug, subjects taking drugs that are contraindicated with haloperidol or olanzapine, subjects with Parkison's Disease, subjects already taking haloperidol, olanzapine, or other antipsychotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea VAS scale | Change from Baseline nausea before medication administration to 60-120 minutes after medication administration | nausea symptoms on a scale of 0-10 with 0 being no nausea and 10 being the worst nausea |
| vomiting | Change from Baseline vomiting before medication administration to 60-120 minutes after medication administration | vomiting symptoms on a scale of 0-10 with 0 being no vomiting and 10 being the worst vomiting |
| abdominal pain | Change from Baseline abdominal pain before medication administration to 60-120 minutes after medication administration | VAS scale abdominal pain symptoms on a scale of 0-10 with 0 being no abdominal pain and 10 being the worst abdominal pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| admission versus discharge | Admission versus discharge status to be determined after the patient has been reassessed for their post medication nausea, vomiting, and abdominal pain VAS score. This occurs 60-120 minutes after study drug administration. | admission versus discharge |
| Ability to tolerate PO | 60-120 minutes after medication administration | Ability to tolerate liquids by mouth, the unit is binary, yes or no |
Countries
United States
Contacts
Primary ContactJoseph Jabour, DO FACEP
Backup ContactAmanda Gutek
Outcome results
None listed