Phase 4
Completed N=100
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Source: ClinicalTrials.gov NCT03605914 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) — 30.2; 40.7 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) |
17.2; 18.9 | — |
| SECONDARY Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) |
17.2; 18.9 | — |
| SECONDARY Number of Participants With Bleeding Complications |
0; 0 | — |
| SECONDARY Number of Participants With Constipation |
— | — |
| SECONDARY Number of Participants With Nausea or Vomiting |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT03605914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.