Nasal Sinus; Inflammation, Opioid Abuse, Pain, Postoperative
Conditions
Keywords
NSAIDs, post-operative pain, post-operative hemorrhage, Functional endoscopic sinus surgery
Brief 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.
Interventions
DRUGIbuprofen 600Mg Tablet
ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.
OTHERStandard 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.
Sponsors
University of Nebraska
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction).
Exclusion criteria
* Not taking anti-coagulation medications including aspirin * Clinical Diagnosis of aspirin-exacerbated respiratory disease * Clinical Diagnosis of Cystic Fibrosis * Clinical Diagnosis of Primary Ciliary Dyskinesia * Inclusion of a Draf III frontal sinusotomy * Clinical Diagnosis of Liver/Kidney Failure * Clinical Diagnosis of Thrombocytopenia * Clinical Diagnosis of Poorly controlled hypertension * Clinical Diagnosis of Recent GI ulcers or gastritis * Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program * Clinical Diagnosis of Primary Headache disorder * The use of nasal decongestants in the post-operative period. * The use of nasal packing or absorbable biomaterials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 1 week | Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication. The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bleeding | 1 week | Any physician visits secondary to bleeding will be tabulated including ER and office visits. |
Countries
United States
Outcome results
None listed