Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty Clinical Trial
Official title:
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
| Verified date | July 2021 |
| Source | The University of Texas Health Science Center, Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 5, 2020 |
| Est. primary completion date | July 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Health Science Center, Houston |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 24 hours (day 1 after operation) | |
| 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. | 48 hours (day 2 after operation) | |
| 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. | 72 hours (day 3 after operation) | |
| 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. | 120 hours (day 5 after operation) | |
| 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. | 5 days after operation | |
| Secondary | Number of Participants With Constipation | 5 days after operation | ||
| Secondary | Number of Participants With Nausea or Vomiting | 5 days after operation |