NCT03404518

Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Quantifying Narcotic Use in Outpatient Otolaryngology Procedures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Outpatient Surgery
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Norco	Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
DRUG	Ibuprofen	Ibuprofen as first line therapy every 6 hours as needed for pain control

Timeline

• Start date: 2018-02-21
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2018-01-19
• Last updated: 2022-03-16
• Results posted: 2022-03-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study