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

NCT04049201 — Not applicable, Completed, 112 participants, Hôpital d'enfants Béchir-Hamza

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Registry	NCT04049201
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	112 (Actual)
Sponsor	Hôpital d'enfants Béchir-Hamza (Other)
Conditions	Anxiety
Interventions	elective surgery, Midazolam, Interactive Tablet (Procedure, drug, device)
Dates	start 2018-05-04, primary completion 2019-05-19, completion 2019-05-19, first posted 2019-08-08, last updated 2019-08-08
Locations	1 site in Tunisia

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group tablet	Experimental	Procedure: elective surgery; Device: Interactive Tablet	group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction
Group Midazolam	Active comparator	Procedure: elective surgery; Drug: Midazolam	group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation

elective surgery (Procedure), also known as we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction: investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
Midazolam (Drug): Oral Midazolam
Interactive Tablet (Device): interactive Tablet containing many cartoon's videos

+Outcome measures

Primary outcomes

Preoperative anxiety [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
Preoperative anxiety [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
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 outcomes

the acceptance of Facial mask [30 minutes after tablet was given]: the acceptance of facial mask by an established score
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 parental satisfaction [1 hour after the wake up of anesthesia]: by an established score

+Eligibility

Sex: All, ages: 3 Years to 10 Years

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

+Locations (1)

Facility	City	Country	Status
Hopital d'Enfants Bechir Hamza	Tunis	Tunisia

My Notes

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