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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
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.
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.
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 30
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 30
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 thirty
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 30
Days participants take to resume their regular diet post operation
Recording how many days it takes for participants to return to their regular diet post operation
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Time frame: From enrollment to post-operative day 30