Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- duration of caudal analgesia
研究概览
简要总结
Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious.
Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.
详细描述
Forty-four children scheduled for hypospadias randomize into 2 groups. Group E (n=22) (0.2% ropivacaine 0.7 ml／kg and S-ketamine 0.5 mg/kg), group C(n=22)( 0.2%ropivacaine 0.7ml／kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. Postoperative pain is assessed using an established 6-item FLACC score at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. A score of more15μg/kg is administered.Investigators propose to compare the duration of caudal analgesia provided by plain ropivacaine and by a mixture of ropivacaine and S-ketamine.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The Patients allocated to study groups using computer generates random list & group assignment is sealed in sequentially numbered opaque envelopes that open after induction of anesthesia.
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •informed parent consent, ASA I or II children, between 3months and 18 years of age,and weighing <28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited.
排除标准
- •Patients who have congenital abnormalities of lower spine and meninges.
- •Patients with hypersensitivity to any local anesthetics
- •Children with coagulation disorders
- •Presence of Infections at puncture sites
- •Preexisting neurological disease
- •Refusal to consent by parent/guardian
研究组 & 干预措施
Group E
the children are given a mixture of 0.2%ropivacaine 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg for caudal analgesia.
干预措施: S-ketamine & Ropivacaine (Drug)
Group C
The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
duration of caudal analgesia
时间窗: 48 hours after the caudal injection
Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.
次要结局
- FLACC score(48 hours after the caudal block)
- morphine consumption(48 hours after caudal block)
- complication(48 hours after the caudal block)
研究者
Tao Zhang
Associate Professor
First Affiliated Hospital, Sun Yat-Sen University