Not Yet RecruitingN/AOther
Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
Sponsored by Fondation Hôpital Saint-Joseph
NCT ID
NCT06373627
Target Enrollment
104 participants
Start Date
2024-05-02
Est. Completion
2025-05-03
About This Study
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.
Conditions Studied
Interventions
- •Hypnosis
- •Conventional medications used for sedation-analgesia
- •Medications used in addition to hypnosis
Eligibility
Age:6 Years - 18 Years
Healthy Volunteers:No
View full 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