Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- The need for additional analgesics during the first 48 hrs after surgery
研究概览
简要总结
Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Despite the fact that this high dose of dexamethasone is used to treat airway edema in actual practice and no adverse side effect related to dosage has been reported, it is 3 to 15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care of anesthesia. Therefore, our study aims to assess the effect of the more practical, antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal block through a non-inferiority trial.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages from 6 months old to 6 years old
- •Body weight Less than or equal to 16.7kg
- •American Society of Anesthesiologists (ASA) classification I or II
- •Patients receiving orchiopexy under general anesthesia
排除标准
- •Patients with uncorrected cardiac anomalies
- •Patients with vertebral anomalies
- •Diagnosis of diabetes mellitus
- •Diagnosis of adrenal disease
- •Currently on steroid
- •Body temperature above 37.5'C preoperatively
- •Allergy to dexamethasone
- •Laparoscopic surgery
研究组 & 干预措施
Dexamethasone
Lower, antiemetic dose of dexamethasone (0.15mg/kg)
干预措施: Low dose dexamethasone (Drug)
Control
Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study
干预措施: High dose dexamethasone (Drug)
结局指标
主要结局
The need for additional analgesics during the first 48 hrs after surgery
时间窗: Until 48 hours after the surgery
The child's parent is to be educated prior to the surgery so that when the pain score (FLACC or Wong-Baker Faces Scale) is 4 or above at home, he or she receives an additional acetaminophen. The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to assess the need for additional analgesics until 48 hours after the surgery.
次要结局
- pain score at each time point(Until 48 hours after the surgery)
- Time to the first additional analgesic(Until 48 hours after the surgery)
- total number of additional analgesic(Until 48 hours after the surgery)
- scale of satisfaction at each time point(Until 48 hours after the surgery)