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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Treatments: Drug: Norco; Drug: diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT03605914

HSC-MS-18-0242

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

NSAID

Experimental group

Description:

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

Treatment:

Drug: diclofenac

opioid

Active Comparator group

Description:

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).

Treatment:

Drug: Norco