Cannabis Hyperemesis Syndrome (CHS) has become a well-documented syndrome since 2004 and is expected to increase in prevalence with continuing liberalization of marijuana and recognition of the disease. Regardless of whether the association with heavy cannabis use is recognized, there is well-documented resistance to traditional anti-emetic treatment. Given promising reports of the use of intravenous haloperidol, a randomized controlled trial comparing it to the commonly administered anti-emetic ondansetron will contribute to the management of CHS
This is a double-blinded, randomized, cross-over clinical trial that will enroll approximately 80 subjects from at least four different research sites. Patients who have been diagnosed with CHS and enrolled in our study will act as their own controls upon their return to the ED for a subsequent bout of CHS for up to 3 visits per subject. Each patient will be allocated in a 1:1:1 fashion into one of three treatment groups: high- or low-dose haloperidol, or ondansetron, with a minimum 7-day washout period between treatments. As CHS tends to be a recurrent syndrome (presumably given the continued use of cannabis despite recommendations to taper and abstain), it is expected that most subjects will return at least once again, and a substantial subset of the study population will complete all three treatment visits during the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Ondansetron 8 MG prepared in a 100 mL normal saline min-bag
Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag
Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag
Hotel Dieu Hospital
Kingston, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Queen's University
Kingston, Ontario, Canada
Change in pain and nausea
Difference between arithmetic mean of Pain Score and Nausea Score (each on a 10-cm VAS) at 2 hours versus at baseline
Time frame: 2 hours
Change in pain
Changes in abdominal pain score at 1, 2, 24 and 48 hours vs. baseline
Time frame: 1, 2, 24 and 48 hours
Change in nausea
Changes in nausea score at 1, 2, 24 and 48 hours vs. baseline
Time frame: 1, 2, 24 and 48 hours
Treatment success
Treatment success = both abdominal pain and nausea score \< 2 at 2, 24 and 48 hours
Time frame: 2, 24 and 48 hours
Oral intake
Cumulative oral intake from t=0 to 2 hours (in mL)
Time frame: 2 hours
Emesis volume
Cumulative emesis from t=0 to 2 hours (in mL)
Time frame: 2 hours
Urine output
Cumulative urine output (in mL)
Time frame: 2 hours
Discharge ready at 2 hours
Deemed discharge-ready at 2 hours in the opinion of the treating physician
Time frame: 2 hours
Rescue anti-emetics in ED
Given rescue anti-emetics prior to discharge
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Time frame: at discharge from Emergency Department or 12 hours whichever comes first
Time to discharge from ED
Time interval to discharge-ready from t=0 (min)
Time frame: at discharge from Emergency Department or 12 hours whichever comes first
Subject preferred arm
Subject preference of high- vs low-dose haloperidol, and of haloperidol vs ondansetron (-10, 10)
Time frame: 2 hours
Return to ED
Unscheduled return visits to ED within 7 days (count)
Time frame: 7 days
ED consult
Consulted to admitting service
Time frame: From time of study intervention until admitting service consulted or subject discharged from Emergency Department, whichever comes first, assessed up to 48 hours
Prolonged ED Length of stay
Outcome 10 "Time to Discharge from ED" \> 12 hours (binary yes/no)
Time frame: at discharge from Emergency Department or 12 hours whichever comes first