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

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).

Study Overview

• Status: Completed
• Conditions: Minimally Invasive Surgery
• Intervention / Treatment: Drug: General anesthesia; Other: Local anesthetic + Hypnosis

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1: General anesthesia; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): January 12, 2018
• Study Completion (ACTUAL): August 12, 2018

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (ESTIMATE): July 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Hypnosis; Anesthesia; Pediatric surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 9518; 2014-A01776-41 (REGISTRY: ID RCB)