Clinical trial NCT04149964: Postoperative Pain Control in Septum and Sinus Surgery
Official title: Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Sinus Surgery
Keywords: Post-operative pain
Sinus pain
Sinus surgery
Septum Pain
deviated septum
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery
* 18 years of age or older
* Male or female
* No known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone
* Patients discharged to home after surgery

Exclusion Criteria:

* Undergoing revision sinus, septum, or sinus/septum surgery
* Younger than 18 years old
* Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone
* Patients admitted to the hospital postoperatively for airway monitoring

Primary outcomes:
measure: Number of Doses of Opiate (Narcotic) Pain Medication
timeFrame: 7 days
Secondary outcomes:
measure: Highest Subjective Pain Score
timeFrame: 7 days
measure: Lowest Subjective Pain Score
timeFrame: 7 days
measure: Percentage of Time Participant Experienced Severe Pain
timeFrame: 7 days
measure: Participant Use of Acetaminophen as Needed
timeFrame: 7 days
measure: Participant Use of Scheduled Acetaminophen Around the Clock
timeFrame: 7 days
measure: Chronic Use of Pain Medication
timeFrame: 7 days
measure: Participant Use of Additional Pain Medication
timeFrame: 7 days
measure: Types of Other Pain Medication Used
timeFrame: 7 days
Other outcomes:
Locations:
city: Farmington Hills
country: United States
facility: Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospital - Farmington Hills
name: David Seel, DO.
role: PRINCIPAL_INVESTIGATOR
References: