Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam (IPAD)

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Paediatric Outpatient Surgery

Treatments: Drug: Midazolam oral intake; Procedure: electronic tab

Study type: Interventional

Funder types: Other

Identifiers

NCT02192710

2013.794

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Hypnovel® (midazolam)

Active Comparator group

Description:

Midazolam oral intake before anesthesia

Treatment:

Drug: Midazolam oral intake

Electronic tab

Experimental group

Treatment:

Procedure: electronic tab