Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Primary Outcome : Pain evaluation by VAS self-assessment
研究概览
简要总结
The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects.
详细描述
Pain and anxiety are common in children with congenital heart disease. They are at risk to develop impaired pain signal processing, and tolerance to opioids and benzodiazepines due to repeated exposure.
Removal of thoracic drains is a standard procedure following cardiac surgery in patients with congenital heart disease. This procedure is usually performed after multimodal sedation-analgesia (intraveinous and inhalation drugs). However, the drugs used (ketamine and midazolam) can have significant side-effects, such as respiratory and circulatory depression.
A few studies have shown the efficacy of therapeutic hypnosis and distractive methods in children, but with a low level of evidence, unlike in adults.
However, none of these studies has evaluated therapeutic hypnosis in children with congenital heart disease.
Hypnosis would be an additional way of better controlling procedural pain, without the side effects of medication. This would reduce the dose of analgesic drugs and improve the pain experience.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ⩾ 6 years and <18 years.
- •Postoperative cardiac surgery patients with intrathoracic drains (pleural or mediastinal).
- •Patients affiliated with or benefiting from a social security or similar scheme.
- •Oral consent obtained from minor children
- •Written consent from the minor's legal representatives
排除标准
- •Psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain
- •Absence of at least 1 legal representative of the minor child
- •French not understood
研究组 & 干预措施
Hypnosis
Hypnosis + MEOPA + direct intravenous Ketamine (0.3 mg/kg) In the event of insufficient analgesia or failure of hypnosis, a 2nd dose of ketamine (0.3 mg/kg) may be administered.
干预措施: Hypnosis (Other)
Hypnosis
Hypnosis + MEOPA + direct intravenous Ketamine (0.3 mg/kg) In the event of insufficient analgesia or failure of hypnosis, a 2nd dose of ketamine (0.3 mg/kg) may be administered.
干预措施: Medications used in addition to hypnosis (Drug)
Conventional sedation-analgesia
MEOPA + direct intravenous Ketamine (0.5 mg/kg) + direct intravenous Midazolam (50 µg/kg) In accordance with current service protocol.
干预措施: Conventional medications used for sedation-analgesia (Drug)
结局指标
主要结局
Primary Outcome : Pain evaluation by VAS self-assessment
时间窗: VAS will be measured 5 minutes before the start of the procedure (T0) and at the end of the procedure (T1) to assess the average pain intensity during drain removal.
The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia does not change level of pain generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6 to 18 years with congenital heart disease, self-assessed by VAS.
次要结局
- Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal(Scoring of the FLACC scale by the evaluator through study completion (up to1 year), blinded to the allocation arm, based on the video recorded during the procedure.)
- Maximum heart rate(The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure)
- Cumulative doses of intravenous analgesics(Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.)
- Respiratory depression(The number of respiratory depression is measured during the intrathoracic drain removal, through the beginning to the end of procedure.)
- Parental satisfaction using Visual Analogic Scale (VAS)(Parents evaluate their satisfaction the day after the procedure (D+1), with a minimal value of 0/10 (e.g no satisfaction), and a maximal value of 10/10 (maximal satisfaction))