Pain Management Following Sinus Surgery

NCT ID: NCT03822962

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-07
• Study Completion Date: 2023-05-30

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.

Detailed Description

National attention has been given to the concerning rise of opioid abuse in this country, with prescriptions for this medications more than quadrupaling in the last 17 years.

Little is known as to the appropriate use of opioid analgesics in the post-operative recovery of patients undergoing sinus surgery. Furthermore, most pain protocols include only Tylenol based opioid analgesics. No study has prospectively evaluated the volume of use of Tylenol based opioid analgesics and whether the addition of NSAIDS decreased the need for opioid analgesics.

This study will compare opioid use with and without the addition of NSAIDS following sinus surgery.

Post-operative opioid use is a great public health concern, relatively unstudied, and an area with an opportunity for potential intervention to significantly reduce risks, morbidity, and mortality to our postoperative patients by better formulating a postoperative pain management plan using evidence-based practices. Appropriate opioid prescribing practices can reduce the risk of addiction, drug overdose, death, and undertreated pain. By optimizing post-operative pain management protocols, the need for opioids following sinus surgery should be minimized.

Conditions

Nasal Sinus; Inflammation; Opioid Abuse; Pain, Postoperative

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Tylenol Regimen

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.

Group Type: OTHER

Standard Regimen | Tylenol

Intervention Type: 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.

Ibuprofen 600mg

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.

Group Type: ACTIVE_COMPARATOR

Ibuprofen 600Mg Tablet

Intervention Type: DRUG

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

Standard Regimen | Tylenol

Intervention Type: 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.

Interventions

Ibuprofen 600Mg Tablet

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

Intervention Type: DRUG

Standard Regimen | Tylenol

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.

Intervention Type: OTHER

Other Intervention Names

Advil, Motrin IB; Acetaminophen

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• Inclusion of a Draf III frontal sinusotomy
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christie Barnes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

0417-18-FB

Identifier Type: -

Identifier Source: org_study_id