Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease (PEACE-HYPNO)

April 15, 2024 updated by: Fondation Hôpital Saint-Joseph

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pain and anxiety are common in children with congenital heart disease. They are at risk to develop impaired pain signal processing, and tolerance to opioids and benzodiazepines due to repeated exposure.

Removal of thoracic drains is a standard procedure following cardiac surgery in patients with congenital heart disease. This procedure is usually performed after multimodal sedation-analgesia (intraveinous and inhalation drugs). However, the drugs used (ketamine and midazolam) can have significant side-effects, such as respiratory and circulatory depression.

A few studies have shown the efficacy of therapeutic hypnosis and distractive methods in children, but with a low level of evidence, unlike in adults.

However, none of these studies has evaluated therapeutic hypnosis in children with congenital heart disease.

Hypnosis would be an additional way of better controlling procedural pain, without the side effects of medication. This would reduce the dose of analgesic drugs and improve the pain experience.

The aim of PEACE-Hypno is to evaluate therapeutic hypnosis as a co-analgesic way of thoracic drain removal in children with congenital heart disease.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypnosis
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

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: Medications used in addition to hypnosis
MEOPA + intravenous ketamine (0.3 mg/kg)
Active Comparator: Conventional sedation-analgesia
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
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome : Pain evaluation by VAS self-assessment
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal
Time Frame: 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.
The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia generates non-inferior pain to that generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6-18 years with congenital heart disease, in hetero-assessment by FLACC by a blinded assigning arm assessor.
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
Time Frame: The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure
Comparison between the two groups of the maximum heart rate during intrathoracic drain removal, measured continuously on a monitor.
The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure
Cumulative doses of intravenous analgesics
Time Frame: Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.
Comparison between the two groups of the cumulative doses of Ketamine and Midazolam used during the procedure.
Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.
Respiratory depression
Time Frame: The number of respiratory depression is measured during the intrathoracic drain removal, through the beginning to the end of procedure.
Comparison between the two groups of the number of episodes of respiratory depression corresponding to a respiratory rate of less than 10/min, measured continuously using the scope.
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)
Time Frame: 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)
Parents evaluate their satisfaction about the procedure, using a VAS self-assessment.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Investigators

  • Principal Investigator: Edouard CHAMBON, Fondation Hôpital Saint-Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 2, 2024

Primary Completion (Estimated)

May 2, 2025

Study Completion (Estimated)

May 3, 2025

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00534-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Disease

Clinical Trials on Hypnosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe