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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone group | Active Comparator | Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization. |
|
| Nausea-observational group | Active Comparator | Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only. |
|
| Hydrocodone/Acetaminophen group | Active Comparator | Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Drug Events | Determine all possible adverse drug events that occurred after the study drugs were administered. | Duration of ED stay, <24 hours. (up to 24 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew A Monte, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
201/502 consented patients did not receive the study medication. The remaining 301 patients were allocated to either one of the opioid treatment groups or the nausea observational group based on what study medication they were prescribed and if they were able to complete serial visual analog scales for pain and nausea.
Recruitment was initiated in the University of Colorado Hospital ED. A convenience sample sample of ED patients were enrolled between June 2012 to January 2013. Subjects were included if they had self-reported pain or nausea identified during the initial nursing assessment. The previous 2 day medication history was obtained during their visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxycodone Group | Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization. |
| FG001 | Hydrocodone/Acetaminophen Group | Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. |
| FG002 | Nausea-observational Group | Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone Group | Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization. |
| BG001 | Hydrocodone/Acetaminophen Group | Subjects given hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | millimeters | Baseline and 90 minutes |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxycodone Group | Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. |
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These data are limited by the nature of self-reported medication ingestion histories and self-reported effectiveness measures for opioid pain medications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew A Monte, MD | University of Colorado | andrew.monte@ucdenver.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D006853 | Hydrocodone |
| C083640 | acetaminophen, hydrocodone drug combination |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Hydrocodone | Drug | Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. |
|
|
| 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. |
|
|
| BG002 | Nausea-observational Group | Patients given ondansetron for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of CYP2D6 drugs taken | Median | Full Range | CYP2D6 drug |
|
Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. |
| OG002 | Nausea-observational Group | Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only. |
|
|
| Secondary | Adverse Drug Events | Determine all possible adverse drug events that occurred after the study drugs were administered. | Posted | Number | participants | Duration of ED stay, <24 hours. (up to 24 hours) |
|
|
|
| 0 |
| 141 |
| 0 |
| 141 |
| EG001 | Hydrocodone/Acetaminophen Group | Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. | 0 | 91 | 0 | 91 |
| EG002 | Nausea-observational Group | Patients given ondansetron by ED provider decision or by triage nurse. This is an observational cohort only. Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization. Ondansetron: Subjects given ondansetron for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only. | 0 | 116 | 0 | 116 |
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |