Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RADA16 | Active Comparator | Patients randomized to the treatment arm will undergo 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. |
|
| Control arm | No Intervention | Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RADA16 hydrogel | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to post-operative day 30. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to post-operative day 30 |
| Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room |
Not provided
Inclusion Criteria:
Children aged 3-17 years undergoing tonsillectomy +/- adenoidectomy CPT codes
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wayne D Hsueh, MD | Contact | 973-972-4588 | wayne.hsueh@rutgers.edu | |
| Gabriel Frimpong, MPH, PA | Contact | 973-972-2309 | gf345@njms.rutgers.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooperman Barnabas Medical Center | Not yet recruiting | Livingston | New Jersey | 07039 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30798778 | Background | Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757. | |
| 23392233 |
Not provided
Not provided
Determining if access to university data can be available for the study
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage |
| 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 | 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 | 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 | From enrollment to post-operative day 30 |
| University Hospital | Recruiting | Newark | New Jersey | 07103 | United States |
|
| Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. |
| 28828761 | Background | Pynnonen M, Brinkmeier JV, Thorne MC, Chong LY, Burton MJ. Coblation versus other surgical techniques for tonsillectomy. Cochrane Database Syst Rev. 2017 Aug 22;8(8):CD004619. doi: 10.1002/14651858.CD004619.pub3. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |