Evaluation of the Analgesic Effect of Tramadol Wound Infiltration in Children Under Inguinal Hernioplasty. A Double-blind, Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain intensity after wound infiltration with tramadol
研究概览
简要总结
Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and vomiting make the tramadol infiltration a technique of interest. There is controversy about its effectiveness.
The local effect of tramadol in hernioplasty was also studied by researchers with some better postoperative analgesia than with local anestetic .
There are few studies with administration of tramadol for hernioplasty, Which led to the interest in this study.
详细描述
The primary objective of the study was to evaluate the analgesic effect of tramadol injected into the surgical incision in patients undergoing hernioplasty.
The study is a prospective, comparative, double covered. The distribution of patients in the groups was randomly drawn prior to starting the project and the groups were identified in envelopes numbered 1-40.
Criteria for inclusion and exclusion After approval by the Ethics Committee of UNIFESP and signature of consent by those responsible, and the term of assent by patients over six years, 40 children of both sexes will be evaluated, aged between 3 and 12 years who underwent hernioplasty.
Children with bleeding disorders, using analgesic or sensitivity to any drug will be excluded.
The patients will be randomly divided into one of two groups. Patients in group 1 will receive local infiltration with 2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution and 20ml of 0.9% saline solution intravenously at the end of the surgical procedure Patients in group 2 will receive 2 mg.kg-1 tramadol intravenously diluted in 20 ml of 0.9% saline solution and local infiltration with 5 mL of saline solution 0.9% at the end of the surgical procedure.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children of both sexes
- •aged between 3 and 12 years
- •underwent hernioplasty
排除标准
- •children with bleeding disorders
- •using analgesic
- •sensitivity to any drug.
研究组 & 干预措施
tramadol wound infiltration
2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution wound infiltration 20ml of 0.9% saline solution intravenously
干预措施: 0.9% saline (Drug)
tramadol wound infiltration
2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution wound infiltration 20ml of 0.9% saline solution intravenously
干预措施: tramadol (Drug)
tramadol intravenous administration
2 mg / kg of tramadol diluted 20ml of 0.9% saline solution intravenously 5 ml of 0.9% saline solution wound infiltration
干预措施: tramadol (Drug)
tramadol intravenous administration
2 mg / kg of tramadol diluted 20ml of 0.9% saline solution intravenously 5 ml of 0.9% saline solution wound infiltration
干预措施: 0.9% saline (Drug)
结局指标
主要结局
Pain intensity after wound infiltration with tramadol
时间窗: 1 month
Faces scale
次要结局
未报告次要终点
研究者
Ana Laura Albertoni Giraldes
doctor
Federal University of São Paulo