Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests
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|ClinicalTrials.gov Identifier: NCT02505880|
Recruitment Status : Unknown
Verified July 2015 by University Hospital, Montpellier.
Recruitment status was: Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Minimally Invasive Surgery||Other: Local anesthetic + Hypnosis Drug: General anesthesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Active Comparator: 1: General anesthesia
Drug: General anesthesia
Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration
Experimental: 2: Hypnosis
Hypnosis with local anesthesia
Other: Local anesthetic + Hypnosis
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)
- Time to "home readiness" [ Time Frame: up to 4 days ]The time to "home readiness" is defined when a patient is ready for discharge using an evidenced-based discharge scoring criteria.
- Postoperative pain [ Time Frame: up to 10 minutes after the entrance to recovery room ]Pain is evaluated after surgery and each hour at hospital by the Faces Pain Scale - Revised (FPS-R).
- Score Induction Compliance Checklist (ICC) [ Time Frame: up to 10 minutes after the entrance to recovery room ]
- Analgesic consumption [ Time Frame: up to 24 hours after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505880
|Montpellier, France, 34295|
|Principal Investigator:||Chrystelle CS Sola, MD||Montpellier University Hospital|