Hepatic Cytochrome Drug Interactions in Emergency Department Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 502
- Locations
- 1
- Primary Endpoint
- Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
Study Overview
Brief Summary
This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.
Detailed Description
Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. Serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •self-reported pain or nausea identified by the initial nursing assessment
Exclusion Criteria
- •unable to speak English,
- •< 18 y.o.,
- •previously diagnosed with chronic pain or cyclic vomiting
Arms & Interventions
Oxycodone group
Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization.
Intervention: Oxycodone (Drug)
Nausea-observational group
Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only.
Intervention: Ondansetron (Drug)
Hydrocodone/Acetaminophen group
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Intervention: Hydrocodone (Drug)
Outcomes
Primary Outcomes
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
Time Frame: Baseline and 90 minutes
Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.
Secondary Outcomes
- Adverse Drug Events(Duration of ED stay, <24 hours. (up to 24 hours))