Analgesic Efficacy of Peritonsillar Ropivacaine Infiltration After Tonsillectomy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to first postoperative analgesic request
研究概览
简要总结
Tonsillectomy is one of the most frequently performed surgical procedures in children and is commonly associated with significant postoperative pain. Peritonsillar infiltration with local anesthetics such as Ropivacaine has been proposed to improve analgesia, but evidence remains inconsistent. This study aimed to evaluate the analgesic efficacy of peritonsillar Ropivacaine infiltration in pediatric tonsillectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant; Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3-6 years
- •classified as ASA I-II
- •scheduled for elective tonsillectomy without adenoidectomy
排除标准
- •systemic diseases (hepatic, renal, hematologic, or cardiac)
- •obesity (BMI ≥ 95th percentile)
- •upper respiratory infection within two weeks
- •chronic analgesic use
- •known allergy to local anesthetics
研究组 & 干预措施
Group 1 (Placebo)
patients will receive peritonsillar infiltration with normal saline
干预措施: Peritonsillar infiltration with normal saline (Other)
Group 1 (Placebo)
patients will receive peritonsillar infiltration with normal saline
干预措施: Normal Saline (Drug)
Group 2 (Ropivacaine)
patients will receive peritonsillar infiltration with ropivacaine
干预措施: Peritonsillar infiltration with ropivacaine (Other)
Group 2 (Ropivacaine)
patients will receive peritonsillar infiltration with ropivacaine
干预措施: ropivacaine (local infiltration) (Drug)
结局指标
主要结局
Time to first postoperative analgesic request
时间窗: From the end of surgery until 24 hours postoperatively
Time from the end of surgery to the first administration of rescue analgesic medication. The time was recorded in hours.
次要结局
- Intraoperative remifentanil dose (µg)(Perioperative.)
- Paracetamol Consumption at 24h(In the first 24 hours postoperatively)
- Time to first oral intake(From the end of surgery until first oral intake, assessed during the first 24 hours after surgery.)
- Face, Legs, Activity, Cry, Consolability scores over 24h(At 0, 2, 4, 8, 12 and 24 hours after surgery)
- Parental satisfaction(At 24 hours after surgery)
- Incidence of adverse effects(Perioperative.)
- Need for rescue tramadol(Perioperative.)
- Surgical conditions(Perioperative.)
- Intraoperative systolic blood pressure(Perioperative.)
- Intraoperative diastolic blood pressure.(Perioperative.)
- Intraoperative heart rate(Perioperative.)
研究者
Hela Attia
Principal Investigator
University Hospital, Mahdia