Paediatric Outpatient SurgeryPhase 3IPADNCT02192710
Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
A Phase 3 study testing electronic tab and Midazolam oral intake in people with Paediatric Outpatient Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Paediatric Outpatient Surgery
- What is being tested?
- electronic tab and Midazolam oral intake
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69500
About this study
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.
Read more
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.
- Conditions
- Paediatric Outpatient Surgery
- Being tested
- electronic tab, Midazolam oral intake
- Keywords
- outpatient surgery, anaesthesia, midazolam, electronic tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic tabProcedure or surgery
classic use of an electronic tab with age specific games
Midazolam oral intakeDrug
| Study group | Role | What they receive |
|---|---|---|
| Hypnovel® (midazolam) | Active comparator | Midazolam oral intake before anesthesia Receives: Drug: Midazolam oral intake |
| Electronic tab | Experimental | Not described Receives: Procedure: electronic tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's level of anxiety
Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0)
Measured: at day 1
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paediatric Outpatient SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192710
- Sponsor's protocol ID
- 2013.794
- Acronym
- IPAD
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28100529
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
- ClinicalTrials.gov ID
- NCT02192710
- Acronym / sponsor ID
- IPAD / 2013.794
- Conditions
- Paediatric Outpatient Surgery
- Keywords
- outpatient surgery, anaesthesia, midazolam, electronic tab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnovel® (midazolam) | Active comparator | Drug: Midazolam oral intakeMidazolam oral intake before anesthesia |
| Electronic tab | Experimental | Procedure: electronic tab |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic tabclassic use of an electronic tab with age specific games | Procedure or surgery | Electronic tab |
| Midazolam oral intake | Drug | Hypnovel® (midazolam) |
Primary outcome
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)
4 secondary outcomes
Patient's level of anxiety
Time frame: At day 1
Parents' level of anxiety
Time frame: At Day 1
Parents' level of anxiety
Time frame: Up to 2 weeks after Day 1
Satisfaction of patients, parents and medical team
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 28100529Marechal 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing electronic tab and Midazolam oral intake in people with Paediatric Outpatient Surgery, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's level of anxiety (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.