Effectiveness of Hypnoanalgesia for Dermatological Surgery in Children: Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Total dose of propofol in mg/kg
研究概览
简要总结
This randomized clinical trial will evaluate the effect of hypnosedation on the need of sedation and analgesia in a pediatric population undergoing dermatological surgery, both during the procedure, and 24 hours after surgery. In addition, a secondary objetive is to evaluate the effect by specific age groups.
详细描述
In this clinical trial, pediatric patients scheduled for removal of benign skin lesions in a single center willbe randomised to receive hypnosis (intervention group) or attention-distracting techniques (control group). Endpoints will be the sedative dose (propofol) during surgery, and the need for analgesia (paracetamol and others) immediately after surgery (recovery) and after 24 hours. Randomization will be systematic in blocks depending on the day the surgery is programmed. Hypnosis will be delivered by an experienced anesthesist trained in the technique. Patients and families will be informed of the special treatment during surgery, but will be unaware of whether the patients are experiencing distraction or hypnosis techniques. Distraction is already a useful technique, and it is expected that patients will be satisfied with the procedure; however, the hypothesis to be tested is that hypnosis reduces the need for sedation and analgesia compared to distraction techniques, as well as improves satisfaction.
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
- Single (Outcomes Assessor)
盲法说明
Different investigators are assigned to each phase of the study, with one designated as responsible for recruitment (MQD), another for intervention and control (JMPP), and another for subsequent evaluation in the post-anaesthesia recovery unit (URPA) and at 24 hours (responsible nursing staff).
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A class I or II of anaesthetic risk according to the American Society of Anesthesiologists,
- •to be in a percentile between P3 and P97 in weight and height,
- •without known drug allergies, and
- •having fasted 6 hours for solids and 2 hours for water.
排除标准
- •Children with diagnosed mental retardation or attention deficit,
- •behavioural disorders,
- •previous treatment with hypnosis,
- •history of neurological pathology or psychomotor retardation,
- •previous pain-related pathology,
- •obstructive sleep apnoea syndrome (OSAS)
结局指标
主要结局
Total dose of propofol in mg/kg
时间窗: During surgery (Intra-operative)
Measured in mg/kg weight
Total dose of propofol in mg
时间窗: During surgery (Intra-operative)
Measured in total mg
Additional need for opioids during surgery
时间窗: During surgery (Intra-operative)
Yes/no
次要结局
- Pain intensity in older children after 24 hours(24 hours after discharge)
- Analgesic need(24 hours after discharge)
- Pain intensity in younger children after 24 hours(24 hours after discharge)
- Pain intensity in younger children post-operative(Immediately post-operative while on recovery unit)
- Pain intensity in older children post-operative(Immediately post-operative while on recovery unit)
- Analgesic needs(24 hours after discharge)
研究者
JUANA MARIA PELAEZ PEREZ
Anesthesiologist
Complejo Hospitalario de Toledo