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

NCT06373627 | Not Yet Recruiting

• 1 other identifier: 2024-A00534-43
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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

Keywords

Congenital Heart Disease; Procedural Pain; Intrathoracic drain; Hypnosis; Pain controlled; Heart surgery

Outcome Measures

Primary Outcomes (1)

• Primary Outcome : Pain evaluation by VAS self-assessment

  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.

  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.

Secondary Outcomes (5)

• Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal

  Scoring of the FLACC scale by the evaluator through study completion (up to1 year), blinded to the allocation arm, based on the video recorded during the procedure.

• Maximum heart rate

  The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure

• Cumulative doses of intravenous analgesics

  Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.

• Respiratory depression

  The number of respiratory depression is measured during the intrathoracic drain removal, through the beginning to the end of procedure.

• Parental satisfaction using Visual Analogic Scale (VAS)

  Parents evaluate their satisfaction the day after the procedure (D+1), with a minimal value of 0/10 (e.g no satisfaction), and a maximal value of 10/10 (maximal satisfaction)

Study Arms (2)

Hypnosis

EXPERIMENTAL

Hypnosis + MEOPA + direct intravenous Ketamine (0.3 mg/kg) In the event of insufficient analgesia or failure of hypnosis, a 2nd dose of ketamine (0.3 mg/kg) may be administered.

Other: Hypnosis; Drug: Medications used in addition to hypnosis

Conventional sedation-analgesia

ACTIVE COMPARATOR

MEOPA + direct intravenous Ketamine (0.5 mg/kg) + direct intravenous Midazolam (50 µg/kg) In accordance with current service protocol.

Drug: Conventional medications used for sedation-analgesia

Interventions

Hypnosis OTHER

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.

Hypnosis

Conventional medications used for sedation-analgesia DRUG

MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)

Conventional sedation-analgesia

Medications used in addition to hypnosis DRUG

MEOPA + intravenous ketamine (0.3 mg/kg)

Hypnosis

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain
• Absence of at least 1 legal representative of the minor child
• French not understood

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Related Publications (19)

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MeSH Terms

Conditions

Pain, Procedural; Heart Defects, Congenital

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Edouard CHAMBON

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie GERARD

CONTACT

0672510756; mariegerard@ymail.com

Sébastien HASCOËT

CONTACT

0140942429; s.hascoet@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 18, 2024
• Study Start: May 2, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 3, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share