Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests

Study Overview
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Brief Summary
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In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia. Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting. In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction. For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia. The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).

Official Title
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Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests

Conditions
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Minimally Invasive Surgery

Intervention / Treatment
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* Other: Local anesthetic + Hypnosis
* Drug: General anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient hospitalized in infantile ambulatory surgery unit Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to III Patient among whom the parents or the legal guardian gave their informed consent Patient member in a national insurance scheme Exclusion Criteria: Patient presenting a contraindication to general anesthesia Patient presenting a contraindication to hypnosis (Chronic Encephalopathy with psychomotor delay, severe cognitive deficit, documented psychiatric disorders)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: General anesthesia<br>General anesthesia | Drug: General anesthesia<br>* Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration<br>|
| Experimental: 2: Hypnosis<br>Hypnosis with local anesthesia | Other: Local anesthetic + Hypnosis<br>* Modified state of consciousness allowing to be at the same time here and somewhere else. The individual is going to dive into his imagination to extract of an uncomfortable situation. And local anesthetic (solution of Xylocaine with adrenaline 1 % dabbed in 20 % of bicarbonate of sodium 4,2 %, maximal dose of 0,5ml / kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to home readiness | The time to home readiness is defined when a patient is ready for discharge using an evidenced-based discharge scoring criteria. | up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Pain is evaluated after surgery and each hour at hospital by the Faces Pain Scale - Revised (FPS-R). | up to 10 minutes after the entrance to recovery room | 
| Score Induction Compliance Checklist (ICC) |  | up to 10 minutes after the entrance to recovery room | 
| Analgesic consumption |  | up to 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis, Pediatric surgery, Anesthesia