2023-503499-25-00招募中4 期
Avoid With locoregional Analgesia Persistant Postoperative Pain After Surgery In Children
Centre Hospitalier Universitaire De Nantes1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2024年2月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery
研究概览
简要总结
To show the positive impact of locoregional Analgesia in the prevention of persistant postoperative Pain after orthopedic trauma surgery in children
研究设计
- 分配方式
- Randomized
- 主要目的
- Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 5 years and < 15 years and 3 month
- •Indication for surgical treatment of a fracture by osteosynthesis
- •Patient affiliated to the social security system
- •Informed and signed consent of patient and one of the two holders of parental authority
- •Conscious patient (Glasgow score =15)
- •Patient can give a verbal assessment of their pain
排除标准
- •Refusal to participate by one of the two holders of parental authority or by the child
- •atrioventricular conduction disorders
- •Sensory neurological deficit of the operated limb on preoperative examination
- •Ischemia of the operated limb on preoperative examination
- •Polytrauma patient
- •Known allergy to Mepivacaine
- •Patient included in a category 1 interventional clinical trial of analgesic therapy
- •Patient on anticoagulant drugs
- •Epilepsy not controlled by a treatment
结局指标
主要结局
Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery
Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery
次要结局
- Response score to DN4 neuropathic pain screening questionnaire ≥4/10 at 3, 6 and 12 months.
- 1st EN score for immediate post-operative care in the Post-Interventional Monitoring Room
- Presence of pain assessed by numerical scale >3/10 at 6 and 12 months post-surgery
- The number of patients experiencing at least one episode of nausea and one episode of vomiting in the Post-Interventional Monitoring Room.
- Duration in minutes of monitoring in the Post-Interventional Monitoring Room
- The dose of intravenous opiates received intraoperatively, the dose of intravenous opiates titrated in the Post-Interventional Monitoring Room and the dose of opiates received in the hospital ward during the first 24 hours postoperatively.
- The dose of IV morphine received in the ICU.
研究者
Dr Rémi Bernardon
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (1)
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