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

NCT06373627 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Edouard CHAMBON · Fondation Hôpital Saint-Joseph

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2025-05-02
Completion
2025-05-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06373627 on ClinicalTrials.gov