Study of the Efficacy and Safety of KALINOX® 170 Bar for the Performance of Care Procedures in Children With Burns
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- The intensity of the pain was assessed using the "Faces Pain Scale Revised"
研究概览
简要总结
The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tunisia and Belgium) study with 8 investigator centers.
详细描述
Pain due to burns is one of the most intense and persistent types of pain. This pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment procedures or burn-care procedures.
Care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain.
Analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. This gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery.
The nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years.
The objective of our study is to obtain qualitative and quantitative data about the efficacy of Kalinox® 170 bar in care procedures in children with burns.
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
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
- •potentially mildly to moderately painful
- •lasting for at least 15 minutes and for less than 30 minutes
- •eligible to receive short-term prophylactic analgesic treatment
- •for whom the consent form has been signed (parent and child)
- •Exclusion criteria:
- •Child treated under general anaesthesia
- •Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.
- •Child suffering from moderate to severe pain when beginning the care procedure (FPSr > 4)
- •Exclusion criteria linked to the product
排除标准
- 未提供
研究组 & 干预措施
A
50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar)
干预措施: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) (Drug)
B
50%Oxygen/50% Nitrogen premix
干预措施: 50%Oxygen/50% Nitrogen premix (Drug)
结局指标
主要结局
The intensity of the pain was assessed using the "Faces Pain Scale Revised"
时间窗: Faces Pain Scale Revised
次要结局
未报告次要终点