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The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAIDS | Active Comparator | 400mg of Ibuprofen |
|
| Opiates | Active Comparator | Norco (hydrocodone 5mg- acetaminophen 325mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norco | Drug | 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Score | Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible) | Day 0 |
| Average Pain Score | Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible) | Day 1 |
| Average Pain Score | Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible) | Day 7 |
| Average Post-Operative Day (POD) of Medication Cessation | Self-reported via Post-Operative Pain Management Survey | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judy Lee, MD | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
All of the individual participant data collected during the trial, after deidentification.
Data are available indefinitely at (Link to be included).
Anyone who wishes to access the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | NSAIDS | 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain |
| FG001 | Opiates | Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NSAIDS | 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain |
| BG001 | Opiates | Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco) |
| 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 | Average Pain Score | Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible) | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
|
7 days
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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 | NSAIDS | 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judy Lee, MD | NYU Langone Health | (646) 501-7906 | Judy.Lee@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2018 | Sep 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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| NSAID |
| Drug |
Ibuprofen 400mg for post-operative pain |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Average Pain Score | Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible) | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| Primary | Average Pain Score | Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible) | Posted | Mean | Standard Deviation | score on a scale | Day 7 |
|
|
|
| Primary | Average Post-Operative Day (POD) of Medication Cessation | Self-reported via Post-Operative Pain Management Survey | Posted | Mean | Standard Deviation | days | Day 7 |
|
|
|
| Secondary | Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain | This outcome measure is only applicable to NSAIDS | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Opiates | Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco) | 0 | 29 | 0 | 29 | 0 | 29 |
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| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |