Emergency Department (ED) Drug Interaction in Emergency Department Patients

Drug Interactions Clinical Trial

Official title:

Hepatic Cytochrome Drug Interactions in Emergency Department Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859715
• Other study ID #: 11-1692
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: May 21, 2013
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Interactions

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in clinically significant visual analogue scale (VAS) change between CYP2D6 users and non-users	Clinically significant visual analogue scale (VAS) oxycodone, hydrocodone, or ondansetron. Clinically significant change defined as 13 mm change.	90 minutes	No
Secondary	Adverse drug events	Determine if there is a difference in ADEs between groups with and without CYP2D6 drug interactions.	Duration of ED stay, <24 hours. (up to 24 hours)	Yes