Congenital Heart Disease, Heart Surgery, Hypnosis, Procedural Pain
Conditions
Keywords
Congenital Heart Disease, Procedural Pain, Intrathoracic drain, Hypnosis, Pain controlled, Heart surgery
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.
Interventions
OTHERHypnosis
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.
DRUGConventional medications used for sedation-analgesia
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
DRUGMedications used in addition to hypnosis
MEOPA + intravenous ketamine (0.3 mg/kg)
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome : Pain evaluation by VAS self-assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Maximum heart rate | 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. |
| Cumulative doses of intravenous analgesics | 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. |
| Respiratory depression | 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. |
| 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) | Parents evaluate their satisfaction about the procedure, using a VAS self-assessment. |
Contacts
Primary ContactMarie GERARD
Backup ContactSébastien HASCOËT
Outcome results
None listed