RADA16 for PedRADA16 for Post-Tonsillectomy Recovery in Children
RADA16 hydrogel
Neurologic Manifestations+4
+ Pain
+ Pain, Postoperative
Treatment Study
Summary
Study start date: December 1, 2025
Actual date on which the first participant was enrolled.This clinical study explores how using a substance called RADA16 during surgery might affect children who have their tonsils removed. Tonsillectomy, or the removal of tonsils, is a common procedure in children but can lead to pain, bleeding, and sometimes the need for additional pain medication afterward. The study aims to see if applying RADA16 during the operation can improve recovery by reducing pain, bleeding, and the need for extra pain relief like oxycodone. This research is important as it could potentially offer a new way to manage postoperative care, making recovery easier and more comfortable for young patients. In this trial, children undergoing tonsillectomy are randomly assigned to two groups. One group receives the usual care, with medications like acetaminophen and NSAIDs, and oxycodone if needed. The other group receives the same medications, but also has RADA16 applied during the surgery. Researchers will monitor the children after surgery to assess pain levels, any bleeding that occurs, if they need to be readmitted to the hospital, and how often they need oxycodone. The goal is to determine if adding RADA16 can provide better results compared to the standard treatment alone.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.134 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 3 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives