PEACE-HYPNO – Management of procedural pain by multimodal sedation analgesia combining hypnosis in children with congenital heart disease: A randomized trial of non-inferiority

Introduction

Children with congenital heart disease often undergo painful procedures due to surgeries and associated care. While medications are commonly used for pain management during procedures like chest tube removal, they can have side effects. Non-pharmacological methods, such as therapeutic hypnosis, have shown effectiveness in reducing procedural pain and anxiety in children. However, there is limited research in this area, particularly in children, and none in children with congenital heart disease.

Objective

The objective of this study is to prove the non-inferiority of therapeutic hypnosis as a co-analgesic compared to standard analgesics during intrathoracic drain removal in children with congenital heart disease.

Methods

This study is a non-inferiority, randomized, controlled trial. Patients are randomized by computer. One group receive the conventional analgesia protocol including ketamine, midazolam, and MEOPA. The other group only receives MEOPA and lower doses of ketamine and undergo a hypnosis session by one of the service's professionals trained in medical hypnosis. Patient pain is self-assessed before and after the procedure. Patients are filmed throughout the drain removal so that per-procedure pain can be blindly evaluated from the randomization arm at a distance from the intervention. Finally, indirect signs of pain (HR, RR, SpO₂) are recorded before, during, and after the intervention.

This study has been authorized by a French Committee of Ethics.

Clinicaltrial.gov: NCT06373627.

Expected results

Therapeutic hypnosis, when combined with minimal sedation-analgesia, is non-inferior to conventional sedation-analgesia in managing pain during chest tube removal in children with congenital heart disease.

Perspectives

This study would pave the way for wider adoption of therapeutic hypnosis as a co-analgesic method for children undergoing painful medical procedures, potentially reducing reliance on medications and enhancing patient experience.