NCT04149964

Postoperative Pain Control in Septum and Sinus Surgery

Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.

Detailed description

Pain control in the postoperative period following septum and/or sinus surgery is controversial, as there is no consensus statement regarding current guidelines to direct clinical practice. Recent legislation limits opioid prescription length to 5 days only, which brings into question whether legislation will affect prescribing practices of physicians and whether or not giving patients an alternative to opiates will be a more efficacious route. Current prescribing practices for septum and sinus surgery of the Otolaryngology private practice group includes as-needed acetaminophen 325 mg and as-needed acetaminophen/hydrocodone 7.5 mg/325 mg. If it can be demonstrated that use of 650 mg acetaminophen in scheduled doses of every 6 hours can decrease postoperative opiate use in the first week without significantly increase in patient pain, this may be deployed as an effective strategy of pain control as the use of opiates has come under scrutiny and attempts are being made to decrease or limit the use of these medications in the medical setting. This study would look to demonstrate that scheduled doses of acetaminophen as opposed to reactionary as-needed acetaminophen can control post-operative pain to the point where narcotics would not be necessary.

Conditions

• Post-operative Pain
• Sinus Surgery

Interventions

Type	Name	Description
DRUG	Acetaminophen 325 mg Oral Tablet	Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
DRUG	Acetaminophen 650 mg Oral Tablet	Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
DRUG	OxyCODONE 5 mg Oral Tablet	Oxycodone 5 mg every 4 hours as needed for breakthrough pain
DRUG	Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet	Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain

Timeline

• Start date: 2019-11-27
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2019-11-04
• Last updated: 2023-08-31
• Results posted: 2023-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study