Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale
研究概览
简要总结
Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old:
- ketorolac 0,5 mg/kg (1 drop every 2 Kg)
- tramadol 2,5 mg/Kh (1 drop every 2 Kg)
Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min.
The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 4-17 years old with not compound bone fracture presenting in emergency room
排除标准
- •Compound fracture
- •Occurring pain still treated
- •Contraindicated ketorolac or tramadol use
- •Informed consensus not obtained
研究组 & 干预措施
1
children 4-17 y. old with not compound bone fracture treated with ketorolac
干预措施: ketorolac (Drug)
2
children 4-17 y. old with not compound bone fracture treated with tramadol
干预措施: tramadol (Drug)
结局指标
主要结局
estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale
时间窗: 6 hours (or until the end of procedures)
次要结局
- comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)(6 hours or until the end of procedures)