Mercy Saint Vincent Medical Center
Toledo, Ohio, 43608, United States
Location status: Recruiting
NCT Number: NCT07246187
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Phase 3
Toledo, Ohio, 43608, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
olanzapine 10 mg IM
Haloperidol 5 mg IM
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 60-120 minutes after medication administration
Ability to tolerate liquids by mouth, the unit is binary, yes or no
Contact information is provided by the study sponsor or research team.
Mercy Bon Secours Saint Vincent Medical Center
Other
Acronym: CH2O
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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