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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-00632 | Other Identifier | NCI-CTRP Clinical Registry |
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To compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery.
Primary Objectives:
The co-primary objectives of this study are as follows:
1. To determine differences in the initial OME prescribed upon discharge between each algorithm/model.
1. To determine OME usage by day 14 after hospital discharge.
Secondary Objectives:
Secondary objectives are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5x-Multiplier Model | Experimental | In this group, you will be given 5 times the amount of opioid medication you needed on your last day in the hospital. You would then use this supply plus standard non-narcotic pain medications. |
|
| 3-Tier Model | Experimental | The total amount of opioid medication you needed on your last day in the hospital to set a maximum number of opioid medications at discharge (up to 30). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocodone | Drug | Given by PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ching-Wei D Tzeng, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40583965 | Derived | Fields BC, Newhook TE, Lillemoe HA, Qiao W, Karam JA, Matin SF, Meyer LA, Tzeng CD. 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-Abdominal Cancer Surgery: Randomized Clinical Trial Protocol. Adv Cancer Educ Qual Improv. 2025;1(1):19. doi: 10.52519/aceqi.25.1.1.a19. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Tramadol |
| Drug |
Given by PO |
|
| Oxycodone | Drug | Given by PO |
|
|
| ID | Term |
|---|---|
| D006853 | Hydrocodone |
| D014147 | Tramadol |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| 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 |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
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