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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
elective surgery
Midazolam
Interactive Tablet
Sponsored by
Hôpital d'enfants Béchir-Hamza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hopital d'Enfants Bechir Hamza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group tablet

Group Midazolam

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

the acceptance of Facial mask
the acceptance of facial mask by an established score
post operative agitation
post operative agitation was assessed using PAEDS which was calculated 10 to 15 minutes after the anesthetic wake up.
the parental satisfaction
by an established score

Full Information

First Posted
March 18, 2019
Last Updated
August 7, 2019
Sponsor
Hôpital d'enfants Béchir-Hamza
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1. Study Identification

Unique Protocol Identification Number
NCT04049201
Brief Title
Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
Official Title
Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
May 19, 2019 (Actual)
Study Completion Date
May 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital d'enfants Béchir-Hamza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group tablet
Arm Type
Experimental
Arm Description
group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction
Arm Title
Group Midazolam
Arm Type
Active Comparator
Arm Description
group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation
Intervention Type
Procedure
Intervention Name(s)
elective surgery
Other Intervention Name(s)
we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction
Intervention Description
investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Oral Midazolam
Intervention Type
Device
Intervention Name(s)
Interactive Tablet
Intervention Description
interactive Tablet containing many cartoon's videos
Primary Outcome Measure Information:
Title
Preoperative anxiety
Description
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
Time Frame
20 minutes after tablet was given
Title
Preoperative anxiety
Description
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
Time Frame
25 minutes after tablet was given
Title
Preoperative anxiety
Description
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
Time Frame
30 minutes after tablet was given
Secondary Outcome Measure Information:
Title
the acceptance of Facial mask
Description
the acceptance of facial mask by an established score
Time Frame
30 minutes after tablet was given
Title
post operative agitation
Description
post operative agitation was assessed using PAEDS which was calculated 10 to 15 minutes after the anesthetic wake up.
Time Frame
10 to 15 minutes after wakeup of anesthesia
Title
the parental satisfaction
Description
by an established score
Time Frame
1 hour after the wake up of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hopital d'Enfants Bechir Hamza
City
Tunis
ZIP/Postal Code
1029
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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