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investigators changed jobs, no longer affiliated with institution
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The purpose of the study is to determine the opiate sparing effects of intravenously administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with well known antiemetic effects. However, the analgesic effects of dexamethasone have not been adequately researched. Following surgery, patients are typically discharged home with PO opiates to manage post-operative pain. The investigators believe that by using VAS (Visual Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1) when compared to placebo.
Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Dexamethasone 8mg iv x 1 |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 8mg iv x1 | Drug | Dexamethasone 8mg iv x1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative VAS Pain Scale | Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Postop Narcotic Usage | Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge | 24 hours |
| Postop Nausea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Fisher, DO | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1 |
| FG001 | Placebo | placebo placebo: placebo administered IV x1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1 |
| BG001 | Placebo | placebo placebo: placebo administered IV x1 |
| 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 | Post Operative VAS Pain Scale | Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
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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 | Intervention | Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lauren Fisher | Beth Israel Deaconess Medical Center | 6176671853 | lauren_fisher@dmgaz.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| placebo |
| Drug |
2 ml normal saline IV x1 |
|
NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
| 24 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Amount of Postop Narcotic Usage | Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge | Posted | Median | Inter-Quartile Range | number of tablets | 24 hours |
|
|
|
|
| Secondary | Postop Nausea | NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined. | Posted | Mean | Inter-Quartile Range | units on a scale | 24 hours |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Placebo | placebo placebo: placebo administered 2 ml normal saline IV x1 | 0 | 41 | 0 | 41 | 0 | 41 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |