The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium

Study Overview
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Brief Summary
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Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .

Detailed Description
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Compare the effects of 0.5 mg/kg oral midazolam, watching film Suko is being operated 'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and playing a game named fishing games on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy. Investigators also evaluated Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores Pain evaluated by FLACC (behoviaral pain assesment scale),at arrive and every 5 minutes for 15 minutes after adenotonsillectomy. Blood pressure(mmHg), heart rate(beat/min) and SpO2(%) measured and recorded at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Official Title
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The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients

Conditions
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Emergence Agitation

Intervention / Treatment
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* Other: Oral midazolam
* Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
* Other: Play game (PC fishing game)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II Pediatric patients Elective surgery Adenotonsillectomi Exclusion Criteria: Cronicdesease Mental retarde Hearing and visual impaired Prematurite

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Effect of pharmacologic or nonpharmacologic premedication on emergency agitation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral midazolam (Demizolam®)<br>To prevent emergence agitation patient premedicated by 0.5 mg oral midazolam At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale). | Other: Oral midazolam<br>* 0.5 mg/kg oral midazolam administered 20 minutes before induction<br>* Other names: Demizolam;|
| Active Comparator: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor<br>To prevent emergence agitation patient premedicated by watching a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale). | Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor<br>* patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.<br>|
| Active Comparator: Play game (PC fishing game)<br>To prevent emergence agitation patient premedicated by playing a simple PC game (fishing game) At the end of sugery patients postoperatif emergence agitation evaluated PAED(pediatric anesthesia emergence delirium scale). | Other: Play game (PC fishing game)<br>* Patients will be played a simple PC game (a fishing game) 20 minutes before induction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation | Emergence agitation will be evaluated by PAED (pediatric anesthesia emergence dellirium).The PAED scale consists of five behaviors, each of which is rated on a five-level scale with a score of zero to four. The scores are added to achieve a total scale score (maximum value is 20). The score above 12 is significant for post operative emergence agitation. | Postoperative every 5 minutes for 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative anxiety | Preoperative anxiety will be evaluated by Modified Yale Preoperative Anxiety Scale ( m-YPAS )scores. Range between 23 to 100. m-YPAS score above 30 is significant to patients anxiety. | 20 minutea after premedications. | 
| Post operative pain | Postoperative pain will be evaluated by behavioral pain scale FLACC(behavioral pain assesment scale). Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0 = Relaxed and comfortable. 1 - 3 = mild discomfort 4 - 6 = moderate pain 7 - 10 = Severe discomfort or pain or both | Postoperative every 5 minutes for 15 minutes | 
| Mean arteriel pressure | Mean arteriel pressure, will be measured. Mean blood pressurre range between 66 to 73 mm Hg is considered normal value. 20% increase in baseline value is considered significant. | Postoperative every 5 minutes for15 minutes | 
| Heart rate | Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant. | Postoperative every 5 minutes for15 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premedication, Pediatric patients, Emergence agitation