Doses Tramadol With Bupivacaine in Penial Block Improve Efficiency of Postoperative Analgésia in Children in Circumcision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Postoperative analgesia
研究概览
简要总结
After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We collected 53 children in each group.
详细描述
After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision. Anesthesia was induced with sevoflurane at 8% and maintained by the same agent at 2%. The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with either tramadol 2mg / Kg (G1: GroupBT ) Or saline serum at the same volume (G2: Group B or control). Postoperative analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic inThe hospital and at home, and by the time of the first demand analgesic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Were scheudled to circumcision surgery
- •Performed by experenced surgeon under general anesthesia
排除标准
- •children with full stomach
- •A history of gastric reflux
- •A history of cardiovascular or neuromuscular disease
- •Allergies to the study drugs
研究组 & 干预措施
G1 (group BT)
The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Tramadol
干预措施: Tramadol (Drug)
G2 (group B or control)
The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative analgesia
时间窗: from awake until 60 min after emergence
Postoperative analgesia was assessed by modified OPS scale, by the number of the number of analgesic in The hospital and home, and by the time of the first demand analgesic.
次要结局
未报告次要终点
研究者
Leila mansali stambouli
Principal Investgator and ClinicalProfessor
University of Monastir