NCT04010032Unknown不适用
The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference in total amount of ropivacaine injected through epidural analgesia
研究概览
简要总结
The aim of this study was to compare the efficacy of a programmed intermittent bolus injection method compared to conventional continuous infusion in the management of epidural analgesia in pediatric patients correctional osteotomy. As a prospective double blinded randomized controlled trial, the investigators compare the quality of pain control after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
triple (Participant, Care Provider, investigator)
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with between 4 and 13 years
- •Patients scheduled for correctional osteotomy of the lower extremity
- •Pediatric patients whose weight of 40kg of less
排除标准
- •Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)
- •Patients with symptoms/signs of elevated intracranial pressure with or without a history of elevated intracranial pressure
- •If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)
结局指标
主要结局
Difference in total amount of ropivacaine injected through epidural analgesia
时间窗: 48 hours after surgery
The difference in the amount of ropivacaine injected into epidural space for 48 hours postoperatively
次要结局
- A dull feeling the patient feels(48 hours after surgery)
- The time for the first patient controlled rescue epidural bolus after surgery(48 hours after surgery)
- Number of patient-controlled rescue epidural bolus for 48 hours postoperatively(48 hours after surgery)
- Pain scores for 6 hours after surgery (VAS)(6 hours after surgery)
- Pain scores for 48 hours after surgery (VAS)(48 hours after surgery)
- Pain scores for 6 hours after surgery (r-FLACC)(6 hours after surgery)
- Pain scores for 12 hours after surgery (VAS)(12 hours after surgery)
- Pain scores for 24 hours after surgery (VAS)(24 hours after surgery)
- Pain scores for 12 hours after surgery (r-FLACC)(12 hours after surgery)
- Pain scores for 24 hours after surgery (r-FLACC)(24 hours after surgery)
- Pain scores for 48 hours after surgery (r-FLACC)(48 hours after surgery)
- Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.(48 hours after surgery)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour AnalgesiaLabor PainNCT03730753Université de Sherbrooke200
已完成
不适用
The Programmed Intermittent Epidural Bolus Adrenaline StudyLabor PainNCT03043781University Hospital, Akershus150
已完成
不适用
PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical TrialPain, PostoperativeNCT03378804Philipps University Marburg Medical Center110
招募中
不适用
Programmed Intermittent Epidural Bolus Compared With Continuous Infusion in Multiparous WomenBreakthrough PainNCT06580327Holy Family Hospital, Nazareth, Israel186
招募中
不适用
PIEB Compared With CEI on Breakthrough Pain in Nulliparous WomenBreakthrough PainNCT06494280Holy Family Hospital, Nazareth, Israel240