Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
- Conditions
- Outpatient SurgeryPain, Postoperative
- Interventions
- Registration Number
- NCT03404518
- Lead Sponsor
- Loma Linda University
- Brief Summary
Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.
- Detailed Description
It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.
The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.
Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
Patients undergoing one of the following outpatient procedure:
- Septoplasty
- Unilateral or Bilateral Functional endoscopic sinus surgery
- Tympanomastoidectomy
- Tympanoplasty
- Total or Partial Thyroidectomy
- Parathyroidectomy
- Parotidectomy.
- Age >18 years and < 89 years
- Age < 18 years or > 89 years
- Post operative hospital admission
- Allergy to Hydrocodone
- Allergy or contraindication to Ibuprofen or NSAIDs
- Pregnancy
- Hepatic disease
- Chronic kidney disease
- Sickle cell anemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Norco and Ibuprofen Norco This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Ibuprofen and Norco Ibuprofen This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.
- Primary Outcome Measures
Name Time Method Narcotic Usage First 7 days after surgery The average number of narcotic pills needed or used for pain control
- Secondary Outcome Measures
Name Time Method Ibuprofen Usage First 7 days after surgery The average number of ibuprofen pills needed or used for pain control
Patient Pain Level Average reported pain for first 7 days after surgery The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.
Trial Locations
- Locations (2)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Loma Linda University Surgical Hospital
🇺🇸Loma Linda, California, United States