Clinical trial NCT02192710: Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
Official title: Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paediatric Outpatient Surgery
Keywords: outpatient surgery
anaesthesia
midazolam
electronic tab
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 118
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient's level of anxiety
timeFrame: at day 1
Secondary outcomes:
measure: Patient's level of anxiety
timeFrame: At day 1
measure: Parents' level of anxiety
timeFrame: At Day 1
measure: Parents' level of anxiety
timeFrame: Up to 2 weeks after Day 1
measure: Satisfaction of patients, parents and medical team
timeFrame: at day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Study officials:
References:
citation: 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.