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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01776-41 | Registry Identifier | ID RCB |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: General anesthesia | Active Comparator | General anesthesia |
|
| 2: Hypnosis | Experimental | Hypnosis with local anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetic + Hypnosis | Other | 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chrystelle CS Sola, MD | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36690538 | Derived | Sola C, Devigne J, Bringuier S, Pico J, Coruble L, Capdevila X, Captier G, Dadure C. Hypnosis as an alternative to general anaesthesia for paediatric superficial surgery: a randomised controlled trial. Br J Anaesth. 2023 Mar;130(3):314-321. doi: 10.1016/j.bja.2022.11.023. Epub 2023 Jan 21. |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D006990 | Hypnosis |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| General anesthesia | Drug | Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration |
|
| up to 10 minutes after the entrance to recovery room |
| Analgesic consumption | up to 24 hours after surgery |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |