NCT06373627

Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease

Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Procedural Pain
• Congenital Heart Disease
• Heart Surgery
• Hypnosis

Interventions

Type	Name	Description
OTHER	Hypnosis	A hypnosis session takes place in 3 stages: * An induction stage, where we move from an ordinary state of consciousness to a modified state of consciousness through dissociation. * A work phase to deepen the hypnotic trance. This phase is fueled by the construction of suggestions and metaphors, analogous to those of the patient in pain. * Finally, a return to the ordinary state of consciousness through re-association with the patient.
DRUG	Conventional medications used for sedation-analgesia	MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
DRUG	Medications used in addition to hypnosis	MEOPA + intravenous ketamine (0.3 mg/kg)

Timeline

• Start date: 2024-05-02
• Primary completion: 2025-05-02
• Completion: 2025-05-03
• First posted: 2024-04-18
• Last updated: 2024-04-18