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Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
Sponsor: Fondation Hôpital Saint-Joseph
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.
Official title: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2024-05-02
Completion Date
2025-05-03
Last Updated
2024-04-18
Healthy Volunteers
No
Interventions
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.
Conventional medications used for sedation-analgesia
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
Medications used in addition to hypnosis
MEOPA + intravenous ketamine (0.3 mg/kg)