- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03605914
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
July 16, 2021 updated by: Martin J Citardi, MD, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- english speaking
- candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
- scheduled for surgery at Texas Sinus Institute
Exclusion Criteria:
- allergy to either NSAIDs or opioids
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NSAID
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
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The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
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ACTIVE_COMPARATOR: 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).
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time Frame: 24 hours (day 1 after operation)
|
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
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24 hours (day 1 after operation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time Frame: 48 hours (day 2 after operation)
|
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)
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Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time Frame: 72 hours (day 3 after operation)
|
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
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72 hours (day 3 after operation)
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Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time Frame: 120 hours (day 5 after operation)
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The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
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120 hours (day 5 after operation)
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Number of Participants With Bleeding Complications
Time Frame: 5 days after operation
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Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.
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5 days after operation
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Number of Participants With Constipation
Time Frame: 5 days after operation
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5 days after operation
|
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Number of Participants With Nausea or Vomiting
Time Frame: 5 days after operation
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5 days after operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Martin Citardi, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2018
Primary Completion (ACTUAL)
July 1, 2020
Study Completion (ACTUAL)
July 5, 2020
Study Registration Dates
First Submitted
July 4, 2018
First Submitted That Met QC Criteria
July 26, 2018
First Posted (ACTUAL)
July 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 16, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Diclofenac
- Hydrocodone
Other Study ID Numbers
- HSC-MS-18-0242
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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