Postoperative Pain Control in Septum and Sinus Surgery

William Beaumont Hospitals

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain; Sinus Surgery

Treatments: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Acetaminophen 325 mg Oral Tablet; Drug: Acetaminophen 650 mg Oral Tablet; Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04149964

2019-259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Standard of Care arm

Active Comparator group

Description:

Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.

Treatment:

Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet

Drug: Acetaminophen 325 mg Oral Tablet

Study Arm

Experimental group

Description:

Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.

Treatment:

Drug: Acetaminophen 650 mg Oral Tablet

Drug: OxyCODONE 5 mg Oral Tablet