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

Minimally Invasive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505880
• Other study ID #: 9518
• Secondary ID: 2014-A01776-41
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 12, 2018

Study information

• Verified date: July 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Minimally Invasive Surgery

Intervention

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)

Drug:
• General anesthesia
Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration

Locations

Country	Name	City	State
France	CHRU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Score Induction Compliance Checklist (ICC)		up to 10 minutes after the entrance to recovery room
Secondary	Analgesic consumption		up to 24 hours after surgery