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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
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.
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
MEOPA + intravenous ketamine (0.3 mg/kg)
Primary Outcome : Pain evaluation by VAS self-assessment
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.
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.
Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal
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.
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.
Maximum heart rate
Comparison between the two groups of the maximum heart rate during intrathoracic drain removal, measured continuously on a monitor.
Time frame: The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure
Cumulative doses of intravenous analgesics
Comparison between the two groups of the cumulative doses of Ketamine and Midazolam used during the procedure.
Time frame: Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.
Respiratory depression
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.
Time frame: 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)
Parents evaluate their satisfaction about the procedure, using a VAS self-assessment.
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)
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