Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07188779

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cooperman Barnabas Medical Center, Livingston, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RADA16 hydrogel

Device

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.

Other names: puragel

Primary outcomes

  1. Postoperative pain

    Time frame: From enrollment to post-operative day 30.

    Pain assessed via the Wong Baker Faces scale. The primary outcome measure will be assessed via online survey on post-operative day one then subsequently every other day until post-operative day fifteen, with a final survey on day 30.

Secondary outcomes

  1. Number of Participants with post-tonsillectomy hemorrhage who receive topical agents

    Time frame: From enrollment to post-operative day 30

    Number of Participants with post-tonsillectomy hemorrhage who receive topical agents for management of post tonsillectomy hemorrhage

  2. Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room

    Time frame: From enrollment to post-operative day 30

    Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage

  3. Number of participants who require hospital readmission for post tonsillectomy hemorrhage management

    Time frame: From enrollment to post-operative day thirty

    Number of participants who require readmission for management of post tonsillectomy hemorrhage

  4. Number of participants who require a rescue analgesic for management following tonsillectomy procedure

    Time frame: From enrollment to post-operative day 30

    Number of participants who use a rescue analgesic following their tonsillectomy procedure

  5. Days participants take to resume their regular diet post operation

    Time frame: From enrollment to post-operative day 30

    Recording how many days it takes for participants to return to their regular diet post operation

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Frimpong, MPH, PA

CONTACT

[email protected]

973-972-2309

Wayne D Hsueh, MD

CONTACT

[email protected]

973-972-4588

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Acronym: RADA16 for Ped

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.