The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium
NCT ID: NCT03426020
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2018-02-20
2018-06-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Oral midazolam (Demizolam®)
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).
Oral midazolam
0.5 mg/kg oral midazolam administered 20 minutes before induction
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
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).
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.
Play game (PC fishing game)
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).
Play game (PC fishing game)
Patients will be played a simple PC game (a fishing game) 20 minutes before induction
Interventions
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Oral midazolam
0.5 mg/kg oral midazolam administered 20 minutes before induction
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.
Play game (PC fishing game)
Patients will be played a simple PC game (a fishing game) 20 minutes before induction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pediatric patients
* Elective surgery
* Adenotonsillectomi
Exclusion Criteria
* Mental retarde
* Hearing and visual impaired
* Prematurite
2 Years
5 Years
ALL
No
Sponsors
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Diskapi Yildirim Beyazit Education and Research Hospital
OTHER_GOV
Responsible Party
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Reyhan Polat
Associate Profesor
Locations
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Reyhan Polat
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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Ministry of Health
Identifier Type: OTHER
Identifier Source: secondary_id
27/11/2017 43/20
Identifier Type: -
Identifier Source: org_study_id
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