Emergency Department (ED) Drug Interaction in Emergency Department Patients

Study Overview
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Brief Summary
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This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.

Detailed Description
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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.

Official Title
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Hepatic Cytochrome Drug Interactions in Emergency Department Patients

Conditions
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Drug Interactions

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Hydrocodone
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone group<br>Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization. | Drug: Oxycodone<br>* Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.<br>* Other names: Oxycodone, oxycontin;|
| Active Comparator: Nausea-observational group<br>Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only. | Drug: Ondansetron<br>* Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.<br>* Other names: Zofran;|
| Active Comparator: Hydrocodone/Acetaminophen group<br>Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. | Drug: Hydrocodone<br>* Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.<br>* Other names: Vicodin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users | 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. | Baseline and 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Events | Determine all possible adverse drug events that occurred after the study drugs were administered. | Duration of ED stay, <24 hours. (up to 24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Interactions, CYP2D6, opioid efficacy, pain, nausea