Emergency Department (ED) Drug Interaction in Emergency Department Patients

NCT01859715 | Completed Results

• 1 other identifier: 11-1692
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Interactions

Keywords

Drug Interactions; CYP2D6; opioid efficacy; pain; nausea

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 90 minutes

Secondary Outcomes (1)

• Adverse Drug Events

  Duration of ED stay, <24 hours. (up to 24 hours)

Study Arms (3)

Oxycodone group

ACTIVE COMPARATOR

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

Drug: Oxycodone

Nausea-observational group

ACTIVE COMPARATOR

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

Drug: Ondansetron

Hydrocodone/Acetaminophen group

ACTIVE COMPARATOR

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

Drug: Hydrocodone

Interventions

Oxycodone DRUG

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

Also known as: Oxycodone, oxycontin

Oxycodone group

Hydrocodone DRUG

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

Also known as: Vicodin

Hydrocodone/Acetaminophen group

Ondansetron DRUG

Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.

Also known as: Zofran

Nausea-observational group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported pain or nausea identified by the initial nursing assessment

You may not qualify if:

• unable to speak English,
• \< 18 y.o.,
• previously diagnosed with chronic pain or cyclic vomiting

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pain; Nausea

Interventions

Oxycodone; Hydrocodone; acetaminophen, hydrocodone drug combination; Ondansetron

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

These data are limited by the nature of self-reported medication ingestion histories and self-reported effectiveness measures for opioid pain medications.

Results Point of Contact

• Title: Andrew A Monte, MD
• Organization: University of Colorado

andrew.monte@ucdenver.edu

Study Officials

• Andrew A Monte, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 22, 2013
• Study Start: June 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 5, 2016
• Results First Posted: May 5, 2016

Record last verified: 2016-04

Locations

US (1)