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NCT Number: NCT02505880

Hypnosis Versus General Anesthesia 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).

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Key information

Conditions

Minimally Invasive Surgery

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Local anesthetic + Hypnosis

Other

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)

General anesthesia

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Score Induction Compliance Checklist (ICC)

    Time frame: up to 10 minutes after the entrance to recovery room

  3. Analgesic consumption

    Time frame: up to 24 hours after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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