Emergency Department (ED) Drug Interaction in Emergency Department Patients

Not Applicable

Completed

• Conditions: Drug Interactions
• Interventions: Drug: Ondansetron; Drug: Oxycodone; Drug: Hydrocodone

• Registration Number: NCT01859715
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2012-06
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-22
• Results First Submitted: 2015-06-09
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-01
• Last Update Submitted: 2016-04-01
• Results First Posted: 2016-05-05
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nausea-observational group	Ondansetron	Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only.
Oxycodone group	Oxycodone	Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization.
Hydrocodone/Acetaminophen group	Hydrocodone	Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.

Primary Outcome Measures

Name	Time	Method
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users	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 Outcome Measures

Name	Time	Method
Adverse Drug Events	Duration of ED stay, <24 hours. (up to 24 hours)	Determine all possible adverse drug events that occurred after the study drugs were administered.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States