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

NCT ID: NCT03605914

Last Updated: 2021-07-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NSAID

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

Group Type EXPERIMENTAL

diclofenac

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Norco

Intervention Type 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).

Interventions

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diclofenac

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

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Hydrocodone-Acetaminophen combination medication

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Martin J Citardi, MD

Professor and Chairman, Department of Otorhinolaryngology - Head and Neck Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Citardi, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MS-18-0242

Identifier Type: -

Identifier Source: org_study_id

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