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

About this trial
This is an interventional other trial for Anxiety
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
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
NCT ID
NCT04049201
First Posted
March 18, 2019
Last Updated
August 7, 2019
Sponsor
Hôpital d'enfants Béchir-Hamza
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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