NCT04049201

Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Hôpital d'enfants Béchir-Hamza · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Anxiety

Interventions

Type	Name	Description
PROCEDURE	elective surgery	investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
DRUG	Midazolam	Oral Midazolam
DEVICE	Interactive Tablet	interactive Tablet containing many cartoon's videos

Timeline

• Start date: 2018-05-04
• Primary completion: 2019-05-19
• Completion: 2019-05-19
• First posted: 2019-08-08
• Last updated: 2019-08-08

Locations

1 site across 1 country: Tunisia