Clinical trial NCT06373627: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
Official title: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Procedural Pain
Congenital Heart Disease
Heart Surgery
Hypnosis
Keywords: Congenital Heart Disease
Procedural Pain
Intrathoracic drain
Hypnosis
Pain controlled
Heart surgery
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The aim of PEACE-Hypno is to evaluate therapeutic hypnosis as a co-analgesic way of thoracic drain removal in children with congenital heart disease.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain
* Absence of at least 1 legal representative of the minor child
* French not understood

Primary outcomes:
measure: Primary Outcome : Pain evaluation by VAS self-assessment
timeFrame: 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.
Secondary outcomes:
measure: Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal
timeFrame: 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.
measure: Maximum heart rate
timeFrame: The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure
measure: Cumulative doses of intravenous analgesics
timeFrame: Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.
measure: Respiratory depression
timeFrame: The number of respiratory depression is measured during the intrathoracic drain removal, through the beginning to the end of procedure.
measure: Parental satisfaction using Visual Analogic Scale (VAS)
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Edouard CHAMBON
role: PRINCIPAL_INVESTIGATOR
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