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

Diskapi Yildirim Beyazit Training and Research Hospital

Status and phase: Unknown; Phase 4

Conditions: Emergence Agitation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03426020

27/11/2017 43/20

Ministry of Health (Other Grant/Funding Number)

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I-II
• Pediatric patients
• Elective surgery
• Adenotonsillectomi

Exclusion criteria

• Cronicdesease
• Mental retarde
• Hearing and visual impaired
• Prematurite

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Oral midazolam (Demizolam®)

Active Comparator group

Description:

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).

Treatment:

Other: Oral midazolam

Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor

Active Comparator group

Description:

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).

Treatment:

Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor

Play game (PC fishing game)

Active Comparator group

Description:

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).

Treatment:

Other: Play game (PC fishing game)