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It didn't get IRB approval.
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This study is looking at whether the addition of Aprepitant (Emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting.
This study is looking at whether the addition of a fairly new drug for the treatment of post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) will provide added efficacy if added to 2 drugs that are already used as a standard of care for PONV and PDNV.
The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on the procedure they are having done and/or on patient risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting | Active Comparator | The addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. |
|
| Standard Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting | No Intervention | No addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant | Drug | Emend 40mg by mouth 30 minutes before procedure x 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| EMEND Added to Standard Treatment of Post-operative and Post-Discharge Nausea and Vomiting | To see if by adding EMEND to a standard treatment regimen for PONV/PDNV, added efficacy will be obtained. To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria A Michaelis, MD | University of Nebraska | Principal Investigator |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D012816 | Signs and Symptoms |