Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children (RADA16 for Ped)

Rutgers The State University of New Jersey

Status and phase: Not yet enrolling; Phase 2

Conditions: Postoperative Pain

Treatments: Device: RADA16 hydrogel

Study type: Interventional

Funder types: Other

Identifiers

NCT07188779

Pro2025001802

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

RADA16

Active Comparator group

Description:

Patients randomized to the treatment arm will undergo application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.

Treatment:

Device: RADA16 hydrogel

Control arm

No Intervention group

Description:

Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.