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

Hôpital d'enfants Béchir-Hamza

Status: Completed

Conditions: Anxiety

Treatments: Drug: Midazolam; Device: Interactive Tablet; Procedure: elective surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04049201

02/2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 3-10 years old children
• elective surgery
• ASA PS I/II

Exclusion criteria

• Parental refusal
• Emergency procedure
• Behavioral or psychiatric disorders
• allergy or hypersensitivity to midazolam

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Group tablet

Experimental group

Description:

group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction

Treatment:

Procedure: elective surgery

Device: Interactive Tablet

Group Midazolam

Active Comparator group

Description:

group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation

Treatment:

Procedure: elective surgery

Drug: Midazolam