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Emergency Department (ED) Drug Interaction in Emergency Department Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01859715
Recruitment Status : Completed
First Posted : May 22, 2013
Results First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Drug Interactions Drug: Oxycodone Drug: Hydrocodone Drug: Ondansetron Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Cytochrome Drug Interactions in Emergency Department Patients
Study Start Date : June 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oxycodone group
Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization.
Drug: Oxycodone
Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
Other Name: Oxycodone, oxycontin

Active Comparator: Nausea-observational group
Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only.
Drug: Ondansetron
Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.
Other Name: Zofran

Active Comparator: Hydrocodone/Acetaminophen group
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Drug: Hydrocodone
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Other Name: Vicodin




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859715


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Andrew A Monte, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01859715    
Other Study ID Numbers: 11-1692
First Posted: May 22, 2013    Key Record Dates
Results First Posted: May 5, 2016
Last Update Posted: May 5, 2016
Last Verified: April 2016
Keywords provided by University of Colorado, Denver:
Drug Interactions
CYP2D6
opioid efficacy
pain
nausea
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Acetaminophen
Acetaminophen, hydrocodone drug combination
Oxycodone
Hydrocodone
Ondansetron
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents