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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02505880
Enrollment
60
Registered
2015-07-22
Start date
2015-06-30
Completion date
2018-08-12
Last updated
2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally Invasive Surgery

Keywords

Hypnosis, Pediatric surgery, Anesthesia

Brief summary

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).

Interventions

OTHERLocal 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)

DRUGGeneral anesthesia

Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Time to home readinessup to 4 daysThe time to home readiness is defined when a patient is ready for discharge using an evidenced-based discharge scoring criteria.

Secondary

MeasureTime frameDescription
Postoperative painup to 10 minutes after the entrance to recovery roomPain is evaluated after surgery and each hour at hospital by the Faces Pain Scale - Revised (FPS-R).
Score Induction Compliance Checklist (ICC)up to 10 minutes after the entrance to recovery room
Analgesic consumptionup to 24 hours after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026