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

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

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Procedure: elective surgery; Device: Interactive Tablet; Drug: Midazolam

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1029
    • Hopital d'Enfants Bechir Hamza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group tablet; group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction	Procedure: elective surgery; investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery; Other Names: we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction; Device: Interactive Tablet; interactive Tablet containing many cartoon's videos
ACTIVE_COMPARATOR: Group Midazolam; group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation	Procedure: elective surgery; investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery; Other Names: we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction; Drug: Midazolam; Oral Midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative anxiety	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	20 minutes after tablet was given
Preoperative anxiety	preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery .the averaged score ranges from 24.9 no anxiety to 100 very anxious	25 minutes after tablet was given
Preoperative anxiety	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	30 minutes after tablet was given

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hôpital d'enfants Béchir-Hamza

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2018
• Primary Completion (ACTUAL): May 19, 2019
• Study Completion (ACTUAL): May 19, 2019

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (ACTUAL): August 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 02/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No