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Opioid Analgesic
Emergency Department (ED) Drug Interaction in Emergency Department Patients
N/A
Waitlist Available
Led By Andrew A Monte, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* self-reported pain or nausea identified by the initial nursing assessment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of ed stay, <24 hours. (up to 24 hours)
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.
Eligible Conditions
- Drug Interaction
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of ed stay, <24 hours. (up to 24 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of ed stay, <24 hours. (up to 24 hours)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
Secondary study objectives
Adverse Drug Events
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Oxycodone groupActive Control1 Intervention
Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization.
Group II: Nausea-observational groupActive Control1 Intervention
Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only.
Group III: Hydrocodone/Acetaminophen groupActive Control1 Intervention
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,662 Total Patients Enrolled
Andrew A Monte, MDPrincipal InvestigatorUniversity of Colorado, Denver