Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following pediatric 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, plus an additional survey on day 30, and track their symptoms.

This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following pediatric 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.

Inclusion Criteria:

Children aged 3-17 years undergoing tonsillectomy +/- adenoidectomy CPT codes

• 42820 (Tonsillectomy and adenoidectomy; younger than age 12)
• 42821 (… age 12 or over)
• 42825 (Tonsillectomy; primary or secondary; younger than age 12)
• 42826 (… age 12 or over)
• 42830 (Adenoidectomy, primary; younger than age 12)
• 42831 (… age 12 or over)
• 42835 (Adenoidectomy; secondary; younger than age 12)
• 42836 (… age 12 or over)

Exclusion Criteria:

• Children with bleeding disorders or other hematologic malignancy or taking anticoagulant medications Developmental delay affecting pain reporting Children with known allergies to RADA16 components Children with prior tonsillectomy or tonsillotomy Children undergoing tonsillectomy with concern for cancer, Children taking opioids chronically prior to surgery, Anyone pregnant women, incarcerated individuals, children unable to speak English or Spanish