Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 4:55 AM
Ignite Modification Date: 2025-12-25 @ 4:55 AM
NCT ID: NCT03404518
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.
Study: NCT03404518
Study Brief:
Protocol Section: NCT03404518