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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02505880
Other study ID # 9518
Secondary ID 2014-A01776-41
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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