Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
- Conditions
- Paediatric Outpatient Surgery
- Interventions
- Procedure: electronic tab
- Registration Number
- NCT02192710
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electronic tab electronic tab - Hypnovel® (midazolam) Midazolam oral intake Midazolam oral intake before anesthesia
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Parents' level of anxiety Up to 2 weeks after Day 1 post-surgery behavioral changes will be measured using the Post Hospitalization Behavioral Questionnaire (PHBQ) at Day+1, day+7 and Day+14 after surgery
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
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
Trial Locations
- Locations (1)
Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
🇫🇷Bron, France