Emergency Department (ED) Drug Interaction in Emergency Department Patients

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Drug Interactions

Treatments: Drug: Ondansetron; Drug: Hydrocodone; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT01859715

11-1692

Details and patient eligibility

About

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

Full 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.

Enrollment: 502 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 3 patient groups

Oxycodone group

Active Comparator group

Description:

Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization.

Treatment:

Drug: Oxycodone

Nausea-observational group

Active Comparator group

Description:

Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only.

Treatment:

Drug: Ondansetron

Hydrocodone/Acetaminophen group

Active Comparator group

Description:

Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.

Treatment:

Drug: Hydrocodone