A Single Center, Randomized Controlled Prospective Double-blinded Trial Comparing Haloperidol to Standard Ondansetron Therapy for Control of Nausea and Vomiting in the Emergency Department
Overview
- Phase
- Phase 4
- Intervention
- Haloperidol
- Conditions
- Vomiting
- Sponsor
- Western Michigan University School of Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Jessica J McCoy, MD FACEP
Clinical Associate Professor
Western Michigan University School of Medicine
Eligibility Criteria
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,
Arms & Interventions
Haloperidol
2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride
Intervention: Haloperidol
Ondansetron
4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride
Intervention: Ondansetron
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: from enrollment to 30, 60, and 90 minutes after drug administration
Mean change in visual analog scale (VAS) of self-rated nausea severity
Secondary Outcomes
- Analgesia(0, 30, 60, 90 minutes)
- Incidence of side-effects(0, 30, 60, 90 minutes and 24 hours)
- Efficacy in marijuana users(Baseline (time 0))
- QT prolongation(Baseline (time 0) and 90 minutes)