Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis

NCT03055507 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00000798
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs due to decreased platelet aggregation and the theoretical risk of increased post-operative bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Additionally, there is a lack of information regarding the average narcotic requirement following ESS. The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This investigation will help to gain understanding of current opioid use in post-op sinus patients and assess the safety and effectiveness of post-operative ibuprofen administration on pain. The investigators aim to quantify the average narcotic use following ESS, as well as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid use in the post-operative period. Additionally, the investigators hypothesize no increase in post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding events. In summary, this will be the first study to the investigators knowledge to examine the effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will be equipped to design and perform the optimal prospective, randomized study evaluating the effect of NSAID in ESS during the post-operative period. The overarching goal of this investigation is to decrease opioid use in post-operative pain control following ESS.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (3)

• Pain Visual Analogue Scale (VAS)

  10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.

  Post-operative day 1

• Pain Visual Analogue Scale

  10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.

  Post-operative day 3

• Pain Visual Analogue Scale

  10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.

  Post-operative day 7

Secondary Outcomes (3)

• Number of Opioid Pills

  Post-operative days 1-7

• Bleeding Visual Analogue Scale

  Post-operative days 1, 3, and 7

• 0-4 Bleeding Scale

  Post-operative days 1, 3, and 7

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN (as needed) pain.

Drug: Acetaminophen 650 mg; Drug: OxyCODONE 5 Mg Oral Tablet

Ibuprofen

EXPERIMENTAL

Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.

Drug: Ibuprofen 400 mg; Drug: Acetaminophen 650 mg; Drug: OxyCODONE 5 Mg Oral Tablet

Interventions

Ibuprofen 400 mg DRUG

Addition of ibuprofen to standard pain regimen.

Also known as: Motrin

Ibuprofen

Acetaminophen 650 mg DRUG

Standard analgesic provided post-operatively to patients undergoing sinus surgery

Also known as: Tylenol, Paracetamol

Control; Ibuprofen

OxyCODONE 5 Mg Oral Tablet DRUG

Standard PRN medication offered post-operatively for breakthrough pain

Control; Ibuprofen

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CRS scheduled to undergo functional endoscopic sinus surgery
• \>18 years old
• Able to speak and comprehend written English

You may not qualify if:

• Contraindication to NSAID use (Chronic kidney disease, Peptic Ulcer disease, Aspirin exacerbated respiratory disorder (AERD), etc.)
• Previous history of bleeding disorder
• Sinus cancer
• Cystic Fibrosis
• Current use of anti-coagulant or anti-platelet medication (during and immediately after ESS)
• History of chronic pain, fibromyalgia, or opioid addiction
• Excessive bleeding during the surgery as determined by the attending surgeon
• Contraindication to acetaminophen use
• Daily use of analgesics including ibuprofen, other NSAIDs, acetaminophen, narcotic medications or other analgesics.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Disease

Interventions

Ibuprofen; Acetaminophen; Oxycodone; Tablets

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Greg Davis, Director of Rhinology and Skull Base
• Organization: University of Washington, Department of Otolaryngology - Head & Neck Surgery

GEDavis@uw.edu

(206) 598-4022

Study Officials

• Craig Miller, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, School of Medicine: Otolaryngology-Head & Neck Surgery

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 16, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 22, 2023
• Results First Posted: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)