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

Not Applicable

Completed

• Conditions: Minimally Invasive Surgery
• Interventions: Drug: General anesthesia; Other: Local anesthetic + Hypnosis

• Registration Number: NCT02505880
• Lead Sponsor: University Hospital, Montpellier

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-15
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Primary Completion: 2018-01-12
• Study Completion: 2018-08-12
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: General anesthesia	General anesthesia	General anesthesia
2: Hypnosis	Local anesthetic + Hypnosis	Hypnosis with local anesthesia

Primary Outcome Measures

Name	Time	Method
Time to "home readiness"	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.

Secondary Outcome Measures

Name	Time	Method
Score Induction Compliance Checklist (ICC)	up to 10 minutes after the entrance to recovery room
Analgesic consumption	up to 24 hours after surgery
Postoperative pain	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).

Trial Locations

Locations (1)

CHRU Montpellier; 🇫🇷 Montpellier, France