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preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders. 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
this study is a prospective,randomized, active treatment controlled trial.It enrolls 100 children . 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.
Age
3 - 10 years
Sex
ALL
Healthy Volunteers
No
Hopital d'Enfants Bechir Hamza
Tunis, Tunisia
Start Date
May 4, 2018
Primary Completion Date
May 19, 2019
Completion Date
May 19, 2019
Last Updated
August 8, 2019
112
ACTUAL participants
elective surgery
PROCEDURE
Midazolam
DRUG
Interactive Tablet
DEVICE
Lead Sponsor
Hôpital d'enfants Béchir-Hamza
NCT07478393
NCT07456631
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