Abdominal Pain, Cannabis Use, Nausea, Vomiting
Conditions
Brief summary
Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.
Interventions
DRUGHaloperidol
2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP
DRUGOndansetron
Ondansetron
Sponsors
Western Michigan University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 150 participants to evaluate for effectiveness and power
Intervention model description
This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ondansetron for the treatment of nausea and vomiting.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* presenting to the emergency department with chief complaint of nausea or vomiting
Exclusion criteria
* abnormal blood pressure (\>200/100mmHg or \<90/40mmHg), * fever (\>100.4F), * acute trauma, * QT \> 450ms on cardiac monitor, * altered mental status (GCS \< 15), * chest pain, * known allergy to haloperidol or ondansetron, * Parkinson's disease, * pregnancy or lactation, * use of any antiemetic in the previous 8 hours, * nausea and vomiting associated with vertigo, * prisoners or any wards of the state.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | from enrollment to 30, 60, and 90 minutes after drug administration | Mean change in visual analog scale (VAS) of self-rated nausea severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia | 0, 30, 60, 90 minutes | Measurement of analgesia graded based on a self-reported validated 10 point visual analog scale (VAS) |
| Efficacy in marijuana users | Baseline (time 0) | Marijuanna use will be documented and quantified |
| QT prolongation | Baseline (time 0) and 90 minutes | QT will be measured on the cardiac monitor |
| Incidence of side-effects | 0, 30, 60, 90 minutes and 24 hours | Inquiry about side effects |
Countries
United States
Outcome results
None listed