Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease (PEACE-HYPNO)

Fondation Hôpital Saint-Joseph

Status: Not yet enrolling

Conditions: Heart Surgery; Hypnosis; Congenital Heart Disease; Procedural Pain

Treatments: Drug: Medications used in addition to hypnosis; Drug: Conventional medications used for sedation-analgesia; Other: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06373627

2024-A00534-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Hypnosis

Experimental group

Description:

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.

Treatment:

Drug: Medications used in addition to hypnosis

Other: Hypnosis

Conventional sedation-analgesia

Active Comparator group

Description:

MEOPA + direct intravenous Ketamine (0.5 mg/kg) + direct intravenous Midazolam (50 µg/kg) In accordance with current service protocol.

Treatment:

Drug: Conventional medications used for sedation-analgesia