NCT03822962

Pain Management Following Sinus Surgery

Post-operative Pain Management Following Functional Endoscopic Sinus Surgery

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Ibuprofen 600Mg Tablet	ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.
OTHER	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.

Timeline

• Start date: 2020-11-07
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2019-01-30
• Last updated: 2023-09-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study