Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Loma Linda University (LLU)

Status and phase: Completed; Phase 3

Conditions: Outpatient Surgery; Pain, Postoperative

Treatments: Drug: Ibuprofen; Drug: Norco

Study type: Interventional

Funder types: Other

Identifiers

NCT03404518

5170252

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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185 participants in 2 patient groups

Norco and Ibuprofen

Experimental group

Description:

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.

Treatment:

Drug: Norco

Ibuprofen and Norco

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen