Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
NCT ID: NCT06373627
Last Updated: 2024-04-18
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
104 participants
INTERVENTIONAL
2024-05-02
2025-05-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Medications used in addition to hypnosis
MEOPA + intravenous ketamine (0.3 mg/kg)
Conventional sedation-analgesia
MEOPA + direct intravenous Ketamine (0.5 mg/kg) + direct intravenous Midazolam (50 µg/kg) In accordance with current service protocol.
Conventional medications used for sedation-analgesia
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
Interventions
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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.
Conventional medications used for sedation-analgesia
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
Medications used in addition to hypnosis
MEOPA + intravenous ketamine (0.3 mg/kg)
Eligibility Criteria
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Inclusion Criteria
* 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
* Absence of at least 1 legal representative of the minor child
* French not understood
6 Years
18 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Edouard CHAMBON
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Central Contacts
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References
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Staveski SL, Boulanger K, Erman L, Lin L, Almgren C, Journel C, Roth SJ, Golianu B. The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study. Pediatr Crit Care Med. 2018 Aug;19(8):725-732. doi: 10.1097/PCC.0000000000001615.
Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. doi: 10.1016/S0140-6736(06)68230-5.
Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.
Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3.
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Other Identifiers
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2024-A00534-43
Identifier Type: -
Identifier Source: org_study_id
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