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Completed

NCT Number: NCT01859715

Emergency Department (ED) Drug Interaction in Emergency Department Patients

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

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Key information

Conditions

Drug Interactions Nausea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

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

Other names: Oxycodone, oxycontin

Hydrocodone

Drug

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

Other names: Vicodin

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.

Other names: Zofran

Primary outcomes

  1. Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users

    Time frame: 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 outcomes

  1. Adverse Drug Events

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

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Hepatic Cytochrome Drug Interactions in Emergency Department Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 22, 2013
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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