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

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.

Study Overview

• Status: Completed
• Conditions: Paediatric Outpatient Surgery
• Intervention / Treatment: Drug: Midazolam oral intake; Procedure: electronic tab

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hypnovel® (midazolam); Midazolam oral intake before anesthesia	Drug: Midazolam oral intake
Experimental: Electronic tab	Procedure: electronic tab; classic use of an electronic tab with age specific games

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's level of anxiety	Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0)	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's level of anxiety	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	At day 1
Parents' level of anxiety	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	At Day 1
Parents' level of anxiety	post-surgery behavioral changes will be measured using the Post Hospitalization Behavioral Questionnaire (PHBQ) at Day+1, day+7 and Day+14 after surgery	Up to 2 weeks after Day 1
Satisfaction of patients, parents and medical team	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	at day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimated): July 17, 2014

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: midazolam; anaesthesia; outpatient surgery; electronic tab
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 2013.794