Comparison of Caudal Bupivacaine Alone With Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Infra-umbilical Surgery: A Randomized Controlled Double Blinded Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Time to first analgesic requirement
研究概览
简要总结
The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1) co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children undergoing infra-umbilical surgery.
详细描述
- Quality assurance plan for data validation and registry: After Data was registered, it was reviewed by a second person who compared it to the Data in patient data collection forms.
- Data check: carried out using Statistical Package for the Social Sciences (SPSS) variable definition protocols. Also data were entered in EXCEL sheets for comparisons to guarantee consistency.
- Source data verification: Paper case report forms and medical records.
- Standard Operating Procedures to address registry operations and analysis activities: Eligible patients were recruited after obtaining consent. Data was collected by qualified personnel rained on the process. Data was entered into Excel sheets and SPSS programs and compared for consistency. Analysis of Data was carried out by a qualified statistician. Adverse events were reported as yes/no variables. Data of patients who had Change in management was omitted from analysis.
- Sample size assessment: Sample size was calculated to detect a 65% reduction in the analgesic requirement during the first 24 h from 75% in the bupivacaine group with α= 0.05 and β=0.80.
- Plan for missing data: Patients with missing Data were omitted from statistical analysis.
- Statistical analysis plan: carried out using International Business Machines (IBM) statistics 19.0 statistical package for windows. Data were compared using analysis of variance for continuous variables, Kruskal-Wallis test for ordinal, and chi square test for categorical ones. Post hoc analyses were carried out as appropriate.
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)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bupivacaine
single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.
干预措施: Bupivacaine (Drug)
dexmedetomidine 1μg.kg-1
Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention
干预措施: dexmedetomidine 1μg.kg-1 (Drug)
dexmedetomidine 2μg.kg-1
Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention
干预措施: dexmedetomidine 2μg.kg-1 (Drug)
结局指标
主要结局
Time to first analgesic requirement
时间窗: 24 hours
The time from end of surgery to the first requirement of postoperative analgesia
Number of postoperative analgesia doses
时间窗: 24 hours
Number of paracetamol doses needed by each patient
Postoperative pain scores
时间窗: 24 hours
次要结局
- Sevoflurane concentration(intraoperative)
- Postoperative sedation scores(2 hours)
- Blood pressure(intraoperative)
- Heart Rate(intraoperative)
- Side effects of study drugs(24 hours)
研究者
Khaled Radian Al-zaben
Dr
University of Jordan