Conditions: Drug Interactions
Keywords: Drug Interactions CYP2D6 opioid efficacy pain nausea
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 502
Healthy volunteers: no

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.

Arms:
arm 1: Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization. arm 2: Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only. arm 3: Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.

Interventions: intervention 1: Oxycodone intervention 2: Hydrocodone intervention 3: Ondansetron
Intervention descriptions: intervention 1: Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization. intervention 2: Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. intervention 3: Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.

Protocol document: