Pain Management Following Sinus Surgery

University of Nebraska

Status and phase: Terminated; Early Phase 1

Conditions: Opioid Abuse; Pain, Postoperative; Nasal Sinus; Inflammation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03822962

0417-18-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Standard Tylenol Regimen

Other group

Description:

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.

Treatment:

Other: Standard Regimen | Tylenol

Ibuprofen 600mg

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen 600Mg Tablet

Other: Standard Regimen | Tylenol