Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
NCT ID: NCT03605914
Last Updated: 2021-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2018-08-01
2020-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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).
Interventions
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diclofenac
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
* scheduled for surgery at Texas Sinus Institute
Exclusion Criteria
* contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
* surgical plan exceeding basic endoscopic sinus surgery
* use of anticoagulation
* the presence of any pain disorder
* the current usage of any analgesic medication
* history of opioid addiction
* pregnancy
* history of chronic pain or fibromyalgia
* current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Martin J Citardi, MD
Professor and Chairman, Department of Otorhinolaryngology - Head and Neck Surgery
Principal Investigators
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Martin Citardi, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-18-0242
Identifier Type: -
Identifier Source: org_study_id
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