Effect Of Peritonsillar Bupivacaine Infiltration on The Development of Postoperative Emergence Delirium After Tonsillectomy In Children: A Randomized, Double-Blind, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pediatric Emergence Delirium Scale
研究概览
简要总结
To evaluate the effect of peritonsillar bupivacaine infiltration on the development of postoperative delirium in pediatric patients undergoing tonsillectomy or adenotonsillectomy.
详细描述
Postoperative emergence delirium (ED) is an important clinical condition characterized by crying, irritability and severe restlessness in subjects recovering from anesthesia. ED is more common in children than in adults. Among the types of surgery, the ED is common in ENT surgery in which the prevalence was reported between 13%-26%. The adenotonsillectomy, which is a common ENT procedure carry a high risk for development of ED.
The ED can cause the child recovering from anesthesia to harm himself/herself and the surgical site and may cause parents to question the quality of anesthesia. It is associated with postoperative increased morbidity. Several anesthetic strategies exists (intranasal premedication, deep versus awake removal of the laryngeal mask, different intravenous anesthetic combinations) in the literature in order to prevent delirium. Local anesthetic application as xylocaine was shown to reduce the postoperative pain and ED. In addition it is generally accepted that that postoperative ED can be reduced with good analgesia.
Local infiltration of peritonsillar fossa with various local anesthetics, steroids etc. is an established technique for relieving the postoperative pain. Bupivacaine as a long-acting local anesthetic is widely used for local infiltration anesthesia. It is a safe technique and several comparative studies exists in the literature on efficacy. A few number of studies exists that evaluates the relationship between effective pain control and postoperative ED development in children with regional anesthesia applications. However, in English literature we could not find a study on the effect of local infiltration of peritonsillar fossa on development of ED in subjects who underwent tonsillectomy/adenotonsillectomy operations.
The aim of this study is to evaluate the effect of peritonsillar bupivacaine infiltration on the development of postoperative delirium in pediatric patients undergoing tonsillectomy/adenotonsillectomy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient have adenotonsillectomy
- •age 3-7 years
排除标准
- •active infection,
- •bleeding-coagulation disorder,
- •neuropsychiatric disorder,
- •bupivacaine hypersensitivity,
- •postoperative delirium history,
- •history of surgery for different reasons within 1 year,
- •history of long-term hospitalization,
- •chronic disease,
- •chronic pain condition
- •chronic analgesic use
研究组 & 干预措施
Group A
Peritonsillar injection was superficially administered to the superior and inferior peritonsillar regions in a volume of 2-5 ml. A 23 Gouge needle syringe was used for injection. A 0.5% Bupivacaine was administered at a dose of 1 mg/kg (maximum dose of 25 mg)
干预措施: peritonsillar bupivacaine injection (Drug)
结局指标
主要结局
Pediatric Emergence Delirium Scale
时间窗: PAED scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.
This scale system was created to evaluate the severity of delirium in children patients. In thİs scale system, patients are graduated between 0 and 20 points. A score of 0 reveals there are no delirium findings, and a score of 20 reveals there is a severe delirium.
次要结局
- Face, Legs, Activity, Cry and Consolability(FLACC scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.)
研究者
Hacer Sebnem Turk
associate professor
Sisli Hamidiye Etfal Training and Research Hospital