Completed

NCT Number: NCT02192710

Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam

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.

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Key information

Conditions

Paediatric Outpatient Surgery

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electronic tab

Procedure

classic use of an electronic tab with age specific games

Midazolam oral intake

Drug

Primary outcomes

Patient's level of anxiety

Time frame: at day 1

Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0)

Secondary outcomes

Patient's level of anxiety

Time frame: 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

Time frame: 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
Parents' level of anxiety

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: IPAD

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 17, 2014
Registry last updated: Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.