Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia in hours.
研究概览
简要总结
The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.
详细描述
The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be achieved by a statistician using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II, III.
- •Patients undergoing lung cyst excision.
- •Patients undergoing Patent Ductus Arteriosus ligation.
排除标准
- •Preoperative mechanical ventilation.
- •Preoperative inotropic support
- •History of mental retardation or delayed development that may interfere with pain intensity assessment
- •Known or suspected coagulopathy,
- •Any congenital anomalies of the sacrum or any infection at the site of injection.
- •Known or suspected allergy to any of the studied drugs.
研究组 & 干预措施
Dexmedetomidine group
A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia.
干预措施: Dexmedetomidine (Drug)
Morphine group
A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia.
干预措施: Morphine (Drug)
结局指标
主要结局
Duration of postoperative analgesia in hours.
时间窗: 3 months
Duration of postoperative analgesia in hours.
次要结局
- Opioid consumption in the first 24 hours post- operative.(3 months)
- The duration of ICU stay in days(3 months)
- Pain score FLACC from 0 to 6(3 months)
- Post operative heart rate(3 months)
研究者
Ahmed Abdelaziz Ismail
Director
Cairo University