Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
NCT ID: NCT04049201
Last Updated: 2019-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
112 participants
INTERVENTIONAL
2018-05-04
2019-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet.
the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety
NCT04273035
Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
NCT02192710
Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients
NCT04135014
Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery
NCT06979791
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
NCT02096900
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
after written and informed consent,the study participants were randomly assigned using a computer generated table to one of two treatment groups prior to elective surgery.
Group T: will receive an interactive tablet containing many cartoon's videos 20 minutes before the parental separation and until the anesthesia induction Group MD:will receive oral midazolam 20 minutes before parental separation with 0.5 mg/kg (max 20mg) Anxiety assessement was done using the Modified Yale Perioperative Anxiety Scale( MYPAS) at the separation of parents,the admission in the operating room and the anesthesia induction.
Facial mask acceptance,post operative agitation (PAEDS score: Pediatric Anesthesia Emergence of Delirium) and parental satisfaction were also assessed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group tablet
group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction
elective surgery
investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
Interactive Tablet
interactive Tablet containing many cartoon's videos
Group Midazolam
group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation
elective surgery
investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
Midazolam
Oral Midazolam
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
elective surgery
investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
Midazolam
Oral Midazolam
Interactive Tablet
interactive Tablet containing many cartoon's videos
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* elective surgery
* ASA PS I/II
Exclusion Criteria
* Emergency procedure
* Behavioral or psychiatric disorders
* allergy or hypersensitivity to midazolam
3 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hôpital d'enfants Béchir-Hamza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Sonia ben khalifa (PhD)
clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital d'Enfants Bechir Hamza
Tunis, , Tunisia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02/2019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.