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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anti-Nausea Rescue Medication
研究概览
简要总结
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).
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Treatment arm of participants will be masked until data collection is complete.
入排标准
- 年龄范围
- 8 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Dextrose
Two doses of dextrose (2ml)
干预措施: Placebo (Drug)
Aprepitant
Two doses of 40mg (2ml) Aprepitant
干预措施: Aprepitant (Drug)
结局指标
主要结局
Anti-Nausea Rescue Medication
时间窗: From surgery end-time until discharge, estimated period of up to 10 days
Anti-nausea rescue medication administered (yes/no).
次要结局
- Baxter Retching Faces score(From surgery end time until discharge,estimated period of up to 10 days)
- Flatus (yes/no)(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)(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(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(From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days)
- Emesis (Yes/No)(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)
- Headache (yes/no)(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)
- Anti-nausea rescue medication administered by post-operative day(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)
- Pain score(From surgery end time until discharge, estimated period of up to 10 days)