Pain Management Following Sinus Surgery

NCT03822962 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: 0417-18-FB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the post-operative pain management of sinus surgery patients and wether or not this addition reduces or eliminates the need for narcotic pain medications. Patients will be instructed to take an NSAID regimen after surgery and will be instructed to take narcotics only for breakthrough pain.

Conditions

Nasal Sinus; Inflammation; Opioid Abuse; Pain, Postoperative

Keywords

NSAIDs; post-operative pain; post-operative hemorrhage; Functional endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

• Pain level

  Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication. The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist.

  1 week

Secondary Outcomes (1)

• Rate of bleeding

  1 week

Study Arms (2)

Standard Tylenol Regimen

OTHER

Patient will be given a standard regimen: Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.

Other: Standard Regimen | Tylenol

Ibuprofen 600mg

ACTIVE COMPARATOR

Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.

Drug: Ibuprofen 600Mg Tablet; Other: Standard Regimen | Tylenol

Interventions

Ibuprofen 600Mg Tablet DRUG

ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.

Also known as: Advil, Motrin IB

Ibuprofen 600mg

Standard Regimen | Tylenol OTHER

Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.

Also known as: Acetaminophen

Ibuprofen 600mg; Standard Tylenol Regimen

Eligibility Criteria

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

You may qualify if:

• All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction).

You may not qualify if:

• Not taking anti-coagulation medications including aspirin
• Clinical Diagnosis of aspirin-exacerbated respiratory disease
• Clinical Diagnosis of Cystic Fibrosis
• Clinical Diagnosis of Primary Ciliary Dyskinesia
• Clinical Diagnosis of Liver/Kidney Failure
• Clinical Diagnosis of Thrombocytopenia
• Clinical Diagnosis of Poorly controlled hypertension
• Clinical Diagnosis of Recent GI ulcers or gastritis
• Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program
• Clinical Diagnosis of Primary Headache disorder
• The use of nasal decongestants in the post-operative period.
• The use of nasal packing or absorbable biomaterials.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0528, United States

Location

MeSH Terms

Conditions

Sinusitis; Opioid-Related Disorders; Pain, Postoperative; Postoperative Hemorrhage

Interventions

Ibuprofen; Tablets; Acetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Christie Barnes, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, cohort study

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: November 7, 2020
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)