Overview
The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy procedures.
Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.
Participants will:
- Undergo tonsillectomy procedure.
- Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.
Description
This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following tonsillectomy as it relates to pain, bleeding, readmission, and use of a rescue analgesic (ex., oxycodone). We propose a randomized controlled trial whereby patients undergoing tonsillectomy would either receive a standard analgesic regimen (postoperative acetaminophen and NSAIDs plus oxycodone as a supplemental analgesic) versus intraoperative RADA16 application plus a standard analgesic regimen.
Eligibility
Inclusion criteria:
Adults undergoing tonsillectomy (CPT codes)
Exclusion criteria:
Patients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy
Patients who have had prior tonsillectomy or tonsillotomy
Patient undergoing tonsillectomy with concern for malignancy
Patients who are on opioids chronically prior to surgery
Patients with an additional indication for pain management (i.e. unrelated to tonsillectomy)
Patients who have been diagnosed with a bleeding disorder or hematologic malignancy
Patients who are on anticoagulants
The following at-risk populations:
Anyone under age 18
Pregnant women
Prisoners
Adults unable to consent (anyone lacking capacity)