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This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.
Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.
Inclusion Criteria:
Patients presenting to the ED with at least one of the following
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prochlorperazine | Active Comparator | Patients receiving Prochlorperazine 10mg IV |
|
| Ondansetron | Active Comparator | Patient receiving Ondansetron 4mg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prochlorperazine | Drug | Patients receiving Prochlorperazine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vomiting at 0 to 120 Min. | 0 to 120 minutes after receiving medication |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea at 0 to 120 Min | 100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea | 0 to 120 minutes after receiving medication |
| Akithisia at 0 to 120 Min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Patka, PharmD | Grady Memorial Hospital | Principal Investigator |
| Daniel T Wu, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Hospital | Atlanta | Georgia | 30303 | United States | ||
| Grady Memorial Hospital |
Patients were excluded if they chose to not participate after being enrolled and receiving medication but did not want to wait be observed for the 120 minute evaluation period.
Patients were recruited at one site (Hospital Emergency Department)over a period of March 2005 to September 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Prochlorperazine | Patients receiving Prochlorperazine 10 mg IV |
| FG001 | Ondansetron | Patients receiving Ondansetron 4mg IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prochlorperazine | Patients receiving Prochlorperazine 10 mg IV |
| BG001 | Ondansetron | Patients receiving Ondansetron 4 mg IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Vomiting at 0 to 120 Min. | Convenience sample | Posted | Number | number of participants exp vomiting | 0 to 120 minutes after receiving medication |
|
|
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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 | Prochlorperazine | Patients receiving Prochlorperazine 10mg IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | Non-systematic Assessment |
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Small sample size due to limited enrollment. Fewer patient in the Odansetron group were discharged home suggesting a possibly sicker baseline group. Complete data sets were not available for all patients due to sedation and participation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Wu | Emory University | (404) 251-8875 | dtwu@emory.edu |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011346 | Prochlorperazine |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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| Ondansetron |
| Drug |
Patients receiving Ondansetron |
|
| 0 to 120 min after receiving medication |
| Atlanta |
| Georgia |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Nausea at 0 to 120 Min | 100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea | Posted | Geometric Mean | Standard Deviation | units on a scale | 0 to 120 minutes after receiving medication |
|
|
|
| Secondary | Akithisia at 0 to 120 Min | Posted | Number | no. participants exp akathisia | 0 to 120 min after receiving medication |
|
|
|
| 3 |
| 32 |
| 0 |
| 32 |
| EG001 | Ondansetron | Patients receiving Ondansetron 4mg IV | 1 | 32 | 0 | 32 |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |