Postoperative Pain
Conditions
Keywords
tonsillectomy, adenoidectomy, hemostasis, postop complications
Brief summary
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.
Detailed description
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.
Interventions
DEVICERADA16 hydrogel
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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with post-tonsillectomy hemorrhage who receive topical agents | From enrollment to post-operative day 30 | Number of Participants with post-tonsillectomy hemorrhage who receive topical agents for management of post tonsillectomy hemorrhage |
| Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room | From enrollment to post-operative day 30 | Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage |
| Number of participants who require hospital readmission for post tonsillectomy hemorrhage management | From enrollment to post-operative day thirty | Number of participants who require readmission for management of post tonsillectomy hemorrhage |
| Number of participants who require a rescue analgesic for management following tonsillectomy procedure | From enrollment to post-operative day 30 | Number of participants who use a rescue analgesic following their tonsillectomy procedure |
| Days participants take to resume their regular diet post operation | From enrollment to post-operative day 30 | Recording how many days it takes for participants to return to their regular diet post operation |
Countries
United States
Contacts
CONTACTWayne D Hsueh, MD
CONTACTGabriel Frimpong, MPH, PA
Outcome results
None listed