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RADA16 for Pain After Tonsillectomy in Children

This study is looking at whether a gel called RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) can help children feel better after a tonsillectomy (surgery to remove tonsils). Researchers want to see if applying RADA16 to the surgical area reduces pain and bleeding. They will compare children who receive RADA16 to those who do not. The study aims to enroll 134 children between 3 and 17 years old who are having a tonsillectomy. The main goal is to see how much pain children experience from the time they enroll until 30 days after surgery. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a randomized controlled trial, where some participants will receive RADA16 and others will not, with a planned enrollment of 134 children.
What's involved
You would undergo a tonsillectomy procedure. You would also fill out surveys sent via email every two days for 15 days after surgery, plus one more survey on day 30, and track your symptoms.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after their surgery to measure postoperative pain.

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NCT07188779

Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

Recruiting
PHASE2Ages 3–17InterventionalTreatment
Rutgers, The State University of New Jersey
~134 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:RADA16 hydrogel

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Postoperative pain
Measured over From enrollment to post-operative day 30.

Conditions

Postoperative Pain

Explore related trials

AdenoidectomyPostoperative HemorrhagePost-Operative PainTonsillectomy

Where it's being run

2 sites across 1 states
New Jersey2

Who to contact

Wayne D Hsueh, MD
[email protected]
973-972-4588
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Postoperative painFrom 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.