A Phase 3 interventional study of Droperidol Injectable Product and Diphenhydramine in Cannabis Hyperemesis Syndrome, sponsored by Mercy Health Ohio. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Mercy Health Ohio · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.
Patients presenting to the Emergency Department with nausea, vomiting and/or abdominal pain with a significant history of cannabis use and symptoms in a cyclic pattern will be assessed for study inclusion. After given written informed consent, patients will be treated with droperidol and diphenhydramine and symptoms will be assessed using a visual analog scale at time intervals up to 120 minutes. Patient will then be contacted at 24 and 48 hour intervals to assess symptoms on the same scale. This is a multicenter, prospective interventional study with results compared to a historical cohort using haloperidol.
Mercy Health Ohio is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once
Drug: Droperidol Injectable Product · Drug: Diphenhydramine
Treatment
Also known as: Inapsine
Treatment
Also known as: Benadryl
Change from baseline in symptoms after treatment with droperidol and diphenhydramine
The Visual Analog Scale is a 100-mm patient-reported score measurement used to assess nausea and/or vomiting and/or abdominal pain. Possible scores range from 0 (symptom-free) to 10 (worst possible symptom)
Time frame: Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.
Plan to share: No
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Droperidol
Cannabinoid Hyperemesis Syndrome
Mercy Health Ohio