Emergency Department (ED) Drug Interaction in Emergency Department Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Drug Interactions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxycodone group

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

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

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

Nausea-observational group

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

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

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

Hydrocodone/Acetaminophen group

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

Group Type ACTIVE_COMPARATOR

Hydrocodone

Intervention Type DRUG

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

Interventions

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Oxycodone

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

Intervention Type DRUG

Hydrocodone

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

Intervention Type 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.

Intervention Type DRUG