Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Overview
- Phase
- Phase 4
- Intervention
- diclofenac
- Conditions
- Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Martin J Citardi, MD
Professor and Chairman, Department of Otorhinolaryngology - Head and Neck Surgery
The University of Texas Health Science Center, Houston
Eligibility Criteria
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)
Arms & Interventions
NSAID
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
Intervention: 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).
Intervention: Norco
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Participants With Constipation(5 days after operation)
- Number of Participants With Nausea or Vomiting(5 days after operation)
- Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)(120 hours (day 5 after operation))
- Number of Participants With Bleeding Complications(5 days after operation)