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Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
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We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal is to screen all patients with pain and enroll enough subjects to reach our goal of 164 evaluable study participants.
Patients will be randomized to one of two study groups. They will then be asked to rate their pain and nausea on a line graph. If the patient is a female of child bearing age, a urine pregnancy test will be done per standard of care. After this, an IV catheter will be placed in a vein in the patients arm. Pain medicine will be given through this IV per the doctor's order. With this medicine, patients will be given 10 milliliters (2 teaspoons) of either Sodium Chloride (salt water) or Phenergan mixed with Sodium Chloride (salt water). Phenergan is a medication typically used to help with nausea and is a common ingredient in prescription cough medicine.
After this is finished, patients will be asked to rate their pain and nausea in 30 minutes, and again 1, 2, and 4 hours later. If the doctor decides the patient is able to be discharged from the emergency room before the 4 hours are up, they will be asked to rate your pain and nausea again before going home, and the study will be stopped at that time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic |
|
| 2 | Active Comparator | Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | 10 c of saline |
| |
| Phenergan |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Became Nauseated After IV Opiate Administration. | 4 hours post opiate administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Perraut, MD | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19718 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic |
| FG001 | Promethazine | Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not enough subjects were enrolled into this study. No analysis of data was performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic |
| BG001 | Promethazine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Patients Who Became Nauseated After IV Opiate Administration. | Posted | Number | participants | 4 hours post opiate administration |
|
|
Subjects were followed for 4 hours post drug/placebo administration.
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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 | Placebo |
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Early termination due to small numbers of subjects and incomplete data for analysis
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deb Marco | Christiana Care Health System | 302-733-4130 | DMarco@christianacare.org |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D011398 | Promethazine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
Physician ordered dose |
|
Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Participants |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Promethazine | 0 | 13 | 0 | 13 |
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| D017670 |
| Sodium Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |