Postoperative Pain
Conditions
Keywords
tonsillectomy, 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 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 and track their symptoms.
Detailed description
This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults undergoing tonsillectomy (CPT codes)
Exclusion criteria
Patients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy Patients who have had prior tonsillectomy or tonsillotomy Patient undergoing tonsillectomy with concern for malignancy Patients who are on opioids chronically prior to surgery Patients with an additional indication for pain management (i.e. unrelated to tonsillectomy) Patients who have been diagnosed with a bleeding disorder or hematologic malignancy Patients who are on anticoagulants The following at-risk populations: Anyone under age 18 Pregnant women Prisoners Adults unable to consent (anyone lacking capacity)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | From enrollment to post-operative day fifteen | Pain assessed via the pain visual analog scale (VAS). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with post-tonsillectomy hemorrhage who receive topical agents | From enrollment to post-operative day fifteen | 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 fifteen | 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 fifteen | 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 fifteen | 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 fifteen | Recording how many days it takes for participants to return to their regular diet post operation |
Countries
United States
Contacts
CONTACTWayne D Hsueh, MD
CONTACTEmily Kwon, BA
PRINCIPAL_INVESTIGATORWayne D Hsueh, MD
Rutgers University
Outcome results
None listed