Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT06373627
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Study Overview
Official Title:
Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEACE-HYPNO
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: