Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children
ConditionPostoperative Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-17
SponsorRutgers, The State University of New Jersey
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
RADA16 hydrogel
DeviceApplication 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 groups
134 Participants
are divided into 2 treatment groupsGroup A: RADA16Active comparator 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Postoperative pain
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.
Time frame
From enrollment to post-operative day 30.Secondary outcomes
1
Number of Participants with post-tonsillectomy hemorrhage who receive topical agents
Number of Participants with post-tonsillectomy hemorrhage who receive topical agents for management of post tonsillectomy hemorrhage
Time frame
From enrollment to post-operative day 302
Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room
Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage
Time frame
From enrollment to post-operative day 303
Number of participants who require hospital readmission for post tonsillectomy hemorrhage management
Number of participants who require readmission for management of post tonsillectomy hemorrhage
Time frame
From enrollment to post-operative day thirty4
Number of participants who require a rescue analgesic for management following tonsillectomy procedure
Number of participants who use a rescue analgesic following their tonsillectomy procedure
Time frame
From enrollment to post-operative day 30Sponsors and contacts
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Source ClinicalTrials.gov