Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: RADA16 hydrogel.
- Кому может быть актуально
- Состояния в реестре: Postoperative Pain. Базовые параметры: 3 лет — 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство RADA16 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.
Первичные конечные точки
- Postoperative pain [Срок оценки: From enrollment to post-operative day 30.]
Вторичные конечные точки (5)
- Number of Participants with post-tonsillectomy hemorrhage who receive topical agents [Срок оценки: From enrollment to post-operative day 30]
- Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room [Срок оценки: From enrollment to post-operative day 30]
- Number of participants who require hospital readmission for post tonsillectomy hemorrhage management [Срок оценки: From enrollment to post-operative day thirty]
- Number of participants who require a rescue analgesic for management following tonsillectomy procedure [Срок оценки: From enrollment to post-operative day 30]
- Days participants take to resume their regular diet post operation [Срок оценки: From enrollment to post-operative day 30]
Критерии участия
Критерии включения
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)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- Cooperman Barnabas Medical Center — Livingston
- University Hospital — Newark
Публикации
- 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. PMID 30798778
- 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. PMID 23392233
- 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. PMID 28828761
Идентификаторы
NCT: NCT07188779 · Pro2025001802