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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Procedure: elective surgery; Device: Interactive Tablet; Drug: Midazolam

• Registration Number: NCT04049201
• Lead Sponsor: Hôpital d'enfants Béchir-Hamza

Brief 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.

Study Timeline

• Study Start: 2018-05-04
• Study First Submitted: 2019-03-18
• Status Verified: 2019-05
• Primary Completion: 2019-05-19
• Study Completion: 2019-05-19
• Study First Submitted QC: 2019-08-07
• Last Update Submitted: 2019-08-07
• Study First Posted: 2019-08-08
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group tablet	elective surgery	group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction
Group tablet	Interactive Tablet	group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction
Group Midazolam	elective surgery	group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation
Group Midazolam	Midazolam	group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety	30 minutes after tablet was given	preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery.the averaged score range from 24.9 no anxiety to 100 very anxious

Secondary Outcome Measures

Name	Time	Method
post operative agitation	10 to 15 minutes after wakeup of anesthesia	post operative agitation was assessed using PAEDS which was calculated 10 to 15 minutes after the anesthetic wake up.
the acceptance of Facial mask	30 minutes after tablet was given	the acceptance of facial mask by an established score
the parental satisfaction	1 hour after the wake up of anesthesia	by an established score

Trial Locations

Locations (1)

Hopital d'Enfants Bechir Hamza; 🇹🇳 Tunis, Tunisia