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Emergency Department (ED) Drug Interaction in Emergency Department Patients

Primary Purpose

Drug Interactions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Hydrocodone
Ondansetron
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Interactions focused on measuring Drug Interactions, CYP2D6, opioid efficacy, pain, nausea

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Oxycodone group

Nausea-observational group

Hydrocodone/Acetaminophen group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Drug Events
Determine all possible adverse drug events that occurred after the study drugs were administered.

Full Information

First Posted
May 1, 2013
Last Updated
April 1, 2016
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01859715
Brief Title
Emergency Department (ED) Drug Interaction in Emergency Department Patients
Official Title
Hepatic Cytochrome Drug Interactions in Emergency Department Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Interactions
Keywords
Drug Interactions, CYP2D6, opioid efficacy, pain, nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone group
Arm Type
Active Comparator
Arm Description
Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization.
Arm Title
Nausea-observational group
Arm Type
Active Comparator
Arm Description
Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only.
Arm Title
Hydrocodone/Acetaminophen group
Arm Type
Active Comparator
Arm Description
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Oxycodone, oxycontin
Intervention Description
Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
Intervention Type
Drug
Intervention Name(s)
Hydrocodone
Other Intervention Name(s)
Vicodin
Intervention Description
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.
Primary Outcome Measure Information:
Title
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
Description
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.
Time Frame
Baseline and 90 minutes
Secondary Outcome Measure Information:
Title
Adverse Drug Events
Description
Determine all possible adverse drug events that occurred after the study drugs were administered.
Time Frame
Duration of ED stay, <24 hours. (up to 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew A Monte, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Emergency Department (ED) Drug Interaction in Emergency Department Patients

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