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

NCT03605914 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-18-0242
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Outcome Measures

Primary Outcomes (1)

• Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

  The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

  24 hours (day 1 after operation)

Secondary Outcomes (6)

• Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

  48 hours (day 2 after operation)

• Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

  72 hours (day 3 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

• Number of Participants With Constipation

  5 days after operation

Study Arms (2)

NSAID

EXPERIMENTAL

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

Drug: diclofenac

opioid

ACTIVE COMPARATOR

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

Interventions

diclofenac DRUG

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

NSAID

Norco DRUG

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).

Also known as: Hydrocodone-Acetaminophen combination medication

opioid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• english speaking
• candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
• scheduled for surgery at Texas Sinus Institute

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Diclofenac; oxycodone-acetaminophen

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Martin J. Citardi, MD, Professor and Chair, Department of Otorhinolaryngology
• Organization: The University of Texas Health Science Center at Houston

Martin.J.Citardi@uth.tmc.edu

(713) 500-5410

Study Officials

• Martin Citardi, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Otorhinolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 30, 2018
• Study Start: August 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 5, 2020
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)