Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NSAID
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
  • Drug: diclofenac
    The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
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).
  • Drug: Norco
    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:
    • Hydrocodone-Acetaminophen combination medication

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.