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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049201
• Other study ID #: 02/2019
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: May 19, 2019

Study information

• Verified date: May 2019
• Source: Hôpital d'enfants Béchir-Hamza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 19, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Procedure:
• elective surgery
investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery

Drug:
• Midazolam
Oral Midazolam

Device:
• Interactive Tablet
interactive Tablet containing many cartoon's videos

Locations

Country	Name	City	State
Tunisia	Hopital d'Enfants Bechir Hamza	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital d'enfants Béchir-Hamza

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	the acceptance of Facial mask	the acceptance of facial mask by an established score	30 minutes after tablet was given
Secondary	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
Secondary	the parental satisfaction	by an established score	1 hour after the wake up of anesthesia