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Completed

NCT Number: NCT04049201

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital d'Enfants Bechir Hamza

Tunis, 1029, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective Surgery

Procedure

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

midazolam

Drug

Oral Midazolam

Interactive Tablet

Device

interactive Tablet containing many cartoon's videos

Primary outcomes

  1. Preoperative anxiety

    Time frame: 20 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

  2. Preoperative anxiety

    Time frame: 25 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 ranges from 24.9 no anxiety to 100 very anxious

  3. Preoperative anxiety

    Time frame: 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 outcomes

  1. the acceptance of Facial mask

    Time frame: 30 minutes after tablet was given

    the acceptance of facial mask by an established score

  2. post operative agitation

    Time frame: 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.

  3. the parental satisfaction

    Time frame: 1 hour after the wake up of anesthesia

    by an established score

Sponsors and collaborators

Lead sponsor

Hôpital d'enfants Béchir-Hamza

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2019
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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