Postoperative Pain Control in Septum and Sinus Surgery

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    200
  • sponsor
    William Beaumont Hospitals
Updated on 19 February 2022
analgesia
opiates
oxycodone

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.

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.

Details
Condition Post-operative Pain, Sinus Surgery
Treatment OxyCODONE 5 Mg Oral Tablet, Acetaminophen 325 mg Oral Tablet, Acetaminophen 650 mg Oral Tablet, Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Clinical Study IdentifierNCT04149964
SponsorWilliam Beaumont Hospitals
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery
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
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