Paediatric Outpatient Surgery
Conditions
Keywords
outpatient surgery, anaesthesia, midazolam, electronic tab
Brief summary
Rationale: The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so coordination between departments and operating room, exposed to the risks of side effects and failure and this variability action. Alternative means were evaluated, such as the presence of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games. Electronic tabs are small devices; light, easy to use with age-specific and interactive programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety and distract children compare to preoperative medication. Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10 years old programmed for a short term and low level of pain outpatient surgery. My pass score will be measured when arriving at the hospital, at the time of the separation with the parents, at the time of the anaesthetic mask induction and after the surgery. 118 patients will be randomized as follows : * Arm 1 : Hypnovel® (midazolam) * Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon area.
Interventions
PROCEDUREelectronic tab
classic use of an electronic tab with age specific games
DRUGMidazolam oral intake
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Girls and boys aged 4 to 10 years, * American Society of Anesthesiologists Score between 1 and 3, * programmed outpatient surgery for a short term and low level of pain * Infection with influenza A virus confirmed with a quick diagnostic test, * informed consent from both parents
Exclusion criteria
* patients younger than 4 or older than 10 years old * preexisting psychiatric disorder with pedo-psychiatric follow-up * children with intellectual disability * psychotropic referred to anxiolytic and / or antipsychotic * history of surgery (n\>=3) * refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's level of anxiety | at day 1 | Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's level of anxiety | At day 1 | Comparison of m-YPAS score between the 2 arms * when arriving at the operating room airlock H-1 before surgery, * at the time of the separation with the parents * 15 minutes before surgery and * 30 minutes before departure from the hospital the same day |
| Parents' level of anxiety | At Day 1 | Evaluation of parents anxiety will be assessed by State-Trait Anxiety Inventory (STAI) : * when arriving at the operating room airlock H-1 before surgery, * at the time of the separation with the parents * 15 minutes before surgery and * 30 minutes before departure from the hospital the same day |
| Satisfaction of patients, parents and medical team | at day 1 | Evaluation of the general satisfaction of children, parents and anesthetic staff will be measured using Visual Analogic Scale (VAS) 30 minutes before departure from the hospital the same day |
Countries
France
Outcome results
None listed