Anxiety
Conditions
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.
Interventions
PROCEDUREelective surgery
investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
DRUGMidazolam
Oral Midazolam
DEVICEInteractive Tablet
interactive Tablet containing many cartoon's videos
Sponsors
Hôpital d'enfants Béchir-Hamza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Tunisia
Outcome results
None listed