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Unable to access EMR for patients enrolled prior to 8/2015 for data collection
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Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.
Previous studies in patients undergoing surgical procedures have shown that when IV dexamethasone is given with IV ondansetron to post-operative patients they have less nausea and vomiting than ondansetron alone, and were even found to show decreased post-operative pain associated with nausea. It has also been shown to decrease the need to re-dose antiemetic medication. Although this combination has not been tested in the emergency department it is believed by these investigators that the additional use of dexamethasone may decrease the need to use repeated doses of ondansetron.
The investigators believe this may change the way physicians currently approach the nauseated patient in regards to treatment. That rather than possibly giving multiple doses of one medication over and over to reduce a patient's nausea, physicians can give two medications together at one time. The investigators hope to demonstrate that by giving intravenous dexamethasone and ondansetron together, it may be possible to reduce the number of patients who need additional doses of nausea medication.
Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron | Active Comparator | Ondansetron (4 mg) followed by two 5 ml normal saline flush |
|
| Ondansetron plus dexamethasone | Experimental | Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Need for Additional Nausea Medications | Effectiveness of intervention will be assessed by the need for additional medications via chart review | 1 hour post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms | Effectiveness of intervention will be assessed by the resolution of symptoms via chart review | 1 hour post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Little, D.O. | Attending Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OhioHealth Doctors Hospital | Columbus | Ohio | 43228 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ondansetron | Ondansetron (4 mg) followed by two 5 ml normal saline flush Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes |
| FG001 | Ondansetron Plus Dexamethasone | Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ondansetron | Ondansetron (4 mg) followed by two 5 ml normal saline flush Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes |
| BG001 | Ondansetron Plus Dexamethasone |
| 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 | Number of Participants With Need for Additional Nausea Medications | Effectiveness of intervention will be assessed by the need for additional medications via chart review | Evaluation of this outcome (need for additional medications within 1 hr of intervention) required additional chart review, which was not performed. As such, this outcome was not collected or analyzed, and cannot be reported. | Posted | 1 hour post intervention |
|
Participants are in the study from time of enrollment until they are discharged from the emergency department. Adverse Events are collected during study enrollment. Incidence of adverse events were collected throughout the patient admission to the Emergency Department, per standard care procedures.
Adverse event reporting followed local, state and federal regulations.
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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 | Ondansetron | Ondansetron (4 mg) followed by two 5 ml normal saline flush Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes |
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Due to the transfer of electronic medical record systems, investigators were unable to access data from patients who were enrolled prior to August 2015 for the retrospective chart review component of this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Blessing, PhD | OhioHealth Research Institutute | (513) 461-1772 | chelsea.blessing@ohiohealth.com |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Dexamethasone | Drug | Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush |
|
|
Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
|
| Secondary | Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms | Effectiveness of intervention will be assessed by the resolution of symptoms via chart review | Evaluation of this outcome (resolution of symptoms following intervention) required additional chart review, which was not collected. As such, this outcome was not collected or analyzed, and cannot be reported. | Posted | 1 hour post intervention |
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Ondansetron Plus Dexamethasone | Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush | 0 | 63 | 0 | 63 | 0 | 63 |
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| D009461 | Neurologic Manifestations |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |