Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- the duration from surgery to first PCA(patient-controlled analgesia) administration
研究概览
简要总结
Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
- •American Society of Anesthesiologists (ASA) classification 1~2
排除标准
- •patients who are having uncorrected heart deformity
- •patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
- •patients with blood coagulopathy
- •patients with diagnosed diabetes
- •patients with diagnosed adrenal disease
- •patients with fever above 37.5 degrees before surgery
- •patients currently taking steroids
- •patients contraindicated for dexamethasone administration
研究组 & 干预措施
control
normal saline is administrated to patients.
干预措施: normal saline (Drug)
dexamethasone
0.5mg/kg dexamethasone is administered to patients.
干预措施: dexamethasone (Drug)
结局指标
主要结局
the duration from surgery to first PCA(patient-controlled analgesia) administration
时间窗: during 48 hours after surgery
the very first time of PCA usage after surgery, which is automatically recorded in PCA.
次要结局
- the amount of additional analgesia required for postoperative 48hrs.(during 48 hours after surgery)
- the number of additional analgesia required for postoperative 48hrs.(during 48 hours after surgery)
- pain score for each time period(during 48 hours after surgery)
- overall parents' satisfaction questionnaire(48 hours after surgery)