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Clinical trial

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

ID
Name
2024-A00534-43
Description
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.
Trial arms
Trial start
2024-05-02
Estimated PCD
2025-05-02
Trial end
2025-05-03
Status
Not yet recruiting
Treatment
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.
Arms:
Hypnosis
Conventional medications used for sedation-analgesia
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
Arms:
Conventional sedation-analgesia
Medications used in addition to hypnosis
MEOPA + intravenous ketamine (0.3 mg/kg)
Arms:
Hypnosis
Size
104
Primary endpoint
Primary Outcome : Pain evaluation by VAS self-assessment
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.
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}
Updated at
2024-04-18

1 organization

2 products

4 indications

Organization
Fondation Hôpital Saint-Joseph
Product
Sedation-Analgesia Conventional Medications
Indication
Procedural Pain
Indication
Congenital Heart Disease
Indication
Heart Surgery
Indication
Hypnosis
Product
Hypnotic medications