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Studies

Interventional Not yet recruiting

NCT06373627 on ClinicalTrials.gov

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

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

  • Sponsor: Hôpital Paris Saint-Joseph
  • Enrollment: 104 (Estimated)
  • Study start: 2024-05-02 (Estimated)
  • Primary completion: 2025-05-02 (Estimated)
  • Study completion: 2025-05-03 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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

Intervention / Treatment

  • Other: Hypnosis
  • Drug: Conventional medications used for sedation-analgesia
  • Drug: Medications used in addition to hypnosis

Primary Outcome Measures

  • 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.)
    The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia does not change level of pain generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6 to 18 years with congenital heart disease, self-assessed by VAS.

Study Officials