Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
NCT ID: NCT02192710
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2013-05-31
2014-04-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypnovel® (midazolam)
Midazolam oral intake before anesthesia
Midazolam oral intake
Electronic tab
electronic tab
classic use of an electronic tab with age specific games
Interventions
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electronic tab
classic use of an electronic tab with age specific games
Midazolam oral intake
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
10 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, , France
Countries
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References
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Marechal C, Berthiller J, Tosetti S, Cogniat B, Desombres H, Bouvet L, Kassai B, Chassard D, de Queiroz Siqueira M. Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction. Br J Anaesth. 2017 Feb;118(2):247-253. doi: 10.1093/bja/aew436.
Other Identifiers
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2013.794
Identifier Type: -
Identifier Source: org_study_id