Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery

Официальное название

A Randomized Controlled Trial Comparing Aprepitant to Standard of Care for Postoperative Nausea and Vomiting Prophylaxis in Children and Adolescents Undergoing Scoliosis Surgery: The APRE-PONV Trial

Обзор

This research trial will measure how useful Aprepitant is in preventing nausea and vomiting in children having surgery to correct scoliosis (curvature of the spine).

Подробное описание

Detailed Description: This prospective, randomized, controlled trial will test whether adding Aprepitant to standard multimodal therapy regimen can further reduce the incidence and severity of post-operative nausea and vomiting (PONV) in children undergoing posterior spinal instrumentation and fusion. The primary outcome of the study will be anti-nausea rescue medication administration post-surgery, with secondary outcomes being the first instance of post-surgery anti-nausea rescue medication administration, emesis, headache, flatus, bowel movement, and sensation of itch; incidence of treatment-emergent adverse events; and worst nausea and pain scores post-surgery .

Вмешательства

• Препарат Aprepitant
  Two doses of 40mg (2ml) Aprepitant. One to be given on the morning of surgery and the second on the morning of post-op day 1
• Препарат Placebo
  Two doses of dextrose syrup (2ml). One to be given on the morning of surgery and the second on the morning of post-op day 1

Первичные конечные точки

• Anti-Nausea Rescue Medication [Срок оценки: From surgery end-time until discharge, estimated period of up to 10 days]

Вторичные конечные точки (9)

• Anti-nausea rescue medication administered by post-operative day [Срок оценки: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days]
• Emesis (Yes/No) [Срок оценки: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days]
• Baxter Retching Faces score [Срок оценки: From surgery end time until discharge,estimated period of up to 10 days]
• Pain score [Срок оценки: From surgery end time until discharge, estimated period of up to 10 days]
• Headache (yes/no) [Срок оценки: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days]
• Flatus (yes/no) [Срок оценки: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days]
• Bowel Motility (yes/no) [Срок оценки: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days]
• Sensation of Itch [Срок оценки: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days]
• Treatment of emergent adverse events [Срок оценки: From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days]

Критерии участия

Критерии включения

• Posterior Spinal Instrumentation and Fusion (PSIF) for idiopathic scoliosis
• The fusion must include at least 6 vertebral levels.
• Children greater than or equal to 8 years old, and less than 19 years old on the day of surgery
• Weight > 40kg - for ease of pharmacy preparation (PONV dose 1mg per kg to max 40mg)

Критерии исключения

• Patient/ Parent refusal
• Hypersensitivity to Aprepitant or any ingredient in the formulation or oral solution. (previous allergy or adverse reaction to Aprepitant)
• Developmental delay as reported by parents
• Pregnant - Pregnancy test done as standard of care pre-operative
• Severe systemic disease ASA classification III or greater
• Concurrent use of any medication with severe interaction with Aprepitant as outlined in product monograph.
• Neuromuscular or congenital scoliosis
• Inability to take PO medications

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

Четверное слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• IWK Health Sciences Center — Halifax

Публикации

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022. PMID 10485781
• Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. PMID 32467512
• Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2. PMID 33075160
• Eberhart LHJ, Geldner G, Kranke P, Morin AM, Schauffelen A, Treiber H, Wulf H. The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients. Anesth Analg. 2004 Dec;99(6):1630-1637. doi: 10.1213/01.ANE.0000135639.57715.6C. PMID 15562045
• Apfel CC, Philip BK, Cakmakkaya OS, Shilling A, Shi YY, Leslie JB, Allard M, Turan A, Windle P, Odom-Forren J, Hooper VD, Radke OC, Ruiz J, Kovac A. Who is at risk for postdischarge nausea and vomiting after ambulatory surgery? Anesthesiology. 2012 Sep;117(3):475-86. doi: 10.1097/ALN.0b013e318267ef31. PMID 22846680
• Kranke P, Eberhart LH, Toker H, Roewer N, Wulf H, Kiefer P. A prospective evaluation of the POVOC score for the prediction of postoperative vomiting in children. Anesth Analg. 2007 Dec;105(6):1592-7, table of contents. doi: 10.1213/01.ane.0000287816.44124.03. PMID 18042855
• Aapro M, Carides A, Rapoport BL, Schmoll HJ, Zhang L, Warr D. Aprepitant and fosaprepitant: a 10-year review of efficacy and safety. Oncologist. 2015 Apr;20(4):450-8. doi: 10.1634/theoncologist.2014-0229. Epub 2015 Mar 20. PMID 25795636
• Salman FT, DiCristina C, Chain A, Afzal AS. Pharmacokinetics and pharmacodynamics of aprepitant for the prevention of postoperative nausea and vomiting in pediatric subjects. J Pediatr Surg. 2019 Jul;54(7):1384-1390. doi: 10.1016/j.jpedsurg.2018.09.006. Epub 2018 Sep 21. PMID 30381138

Идентификаторы

NCT: NCT06357234 · APRE-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗