RADA16 gel to help kids recover after tonsillectomy
Official title: Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children
Run by Rutgers, The State University of New Jersey · NCT07188779 · Data updated 2026-11-12
This study tests whether applying RADA16 gel during pediatric tonsillectomy improves recovery compared with standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 134 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (Livingston, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | July 9, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07188779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3–17 undergoing tonsillectomy (with or without adenoidectomy) who have no bleeding disorders or allergies to RADA16 components and can communicate in English or Spanish.
✕Probably not a fit
Patients with bleeding disorders, prior tonsil surgery, chronic opioid use, or other exclusion criteria may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized Phase 2 trial, children aged 3–17 undergoing tonsillectomy (with or without adenoidectomy) will be assigned to receive intraoperative RADA16 hydrogel plus standard analgesia or standard analgesia alone. The study monitors postoperative pain, bleeding, readmissions, and need for rescue analgesia, using surveys up to 30 days after surgery. Outcomes will indicate if RADA16 can improve postoperative recovery and reduce complications in pediatric tonsillectomy.
Why it matters
Potential benefit: If successful, RADA16 could reduce pain and bleeding after tonsillectomy and improve overall recovery in children.
How similar studies have gone: Previous studies in similar surgical contexts suggest potential benefits of barrier/adhesive gels, but this exact pediatric tonsillectomy approach is being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital
Newark, New Jersey, United States Recruiting -
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States Not yet recruiting
Study contacts
- Study coordinator: Wayne D Hsueh, MD
- Email: wayne.hsueh@rutgers.edu
- Phone: 973-972-4588
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.