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The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAID | Experimental | The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. |
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| opioid | Active Comparator | The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac | Drug | The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | 24 hours (day 1 after operation) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | 48 hours (day 2 after operation) |
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Citardi, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NSAID | The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. |
| FG001 | Opioid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 26, 2018 |
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| Norco | Drug | The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). |
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The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
| 72 hours (day 3 after operation) |
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | 120 hours (day 5 after operation) |
| Number of Participants With Bleeding Complications | Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis. | 5 days after operation |
| Number of Participants With Constipation | 5 days after operation |
| Number of Participants With Nausea or Vomiting | 5 days after operation |
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
| Completed Day 1 Assessment |
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| Completed Day 2 Assessment |
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| Completed Day 3 Assessment |
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| Completed Day 5 Assessment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NSAID | The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. |
| BG001 | Opioid | The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of participants with history of anxiety | Count of Participants | Participants |
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| Number of participants with history of depression | Count of Participants | Participants |
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| Number of participants with history of migraine | Count of Participants | Participants |
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| Number of participants with history of temporomandibular joint (TMJ) dysfunction | Count of Participants | Participants |
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| Number of participants with history of fibromyalgia | Count of Participants | Participants |
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| Number of participants with history of pain disorder | Count of Participants | Participants |
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| Number of participants currently on pain medication | Count of Participants | Participants |
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| Number of participants currently on opioid | Count of Participants | Participants |
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| Number of participants currently on NSAID | Count of Participants | Participants |
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| 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 | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | Data was not collected for 26 in the NSAID arm and 17 in the opioid arm. | Posted | Mean | Standard Deviation | units on a scale | 24 hours (day 1 after operation) |
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| Secondary | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | Data was not collected for 25 in the NSAID arm and 16 in the opioid arm. | Posted | Mean | Standard Deviation | units on a scale | 48 hours (day 2 after operation) |
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| Secondary | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | Data was not collected for 26 in the NSAID arm and 15 in the opioid arm. | Posted | Mean | Standard Deviation | units on a scale | 72 hours (day 3 after operation) |
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| Secondary | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. | Data was not collected for 27 in the NSAID arm and 19 in the opioid arm. | Posted | Mean | Standard Deviation | units on a scale | 120 hours (day 5 after operation) |
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| Secondary | Number of Participants With Bleeding Complications | Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis. | Data was not collected for 27 in the NSAID arm and 19 in the opioid arm. | Posted | Count of Participants | Participants | 5 days after operation |
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| Secondary | Number of Participants With Constipation | No data were collected for this outcome measure. | Posted | 5 days after operation |
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| Secondary | Number of Participants With Nausea or Vomiting | No data were collected for this outcome measure. | Posted | 5 days after operation |
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5 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 | NSAID | The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. | 0 | 57 | 0 | 57 | 0 | 57 |
| EG001 | Opioid | The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). | 0 | 43 | 0 | 43 | 0 | 43 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin J. Citardi, MD, Professor and Chair, Department of Otorhinolaryngology | The University of Texas Health Science Center at Houston | (713) 500-5410 | Martin.J.Citardi@uth.tmc.edu |
| Jun 25, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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