CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
diclofenac +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • English speaking
  • Candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
  • Scheduled for surgery at Texas Sinus Institute
Key exclusion· 10
  • Allergy to NSAIDs or opioids
  • Contraindication to NSAIDs (e.g., gastritis, chronic kidney disease)
  • Surgical plan exceeding basic endoscopic sinus surgery
  • Use of anticoagulation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03605914
NCT03605914Phase 4Completed

Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

The University of Texas Health Science Center, Houston·interventional·Posted Jul 30, 2018·Updated Jul 20, 2021

In Brief

A Phase 4 clinical trial evaluating diclofenac and Norco for Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 30, 2018
Enrollment StartAug 1, 2018
Primary CompletionJul 1, 2020
Study CompletionJul 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.9 years ago

Interventions

diclofenacdrug

The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.

Norcodrug

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).