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

D

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

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)

Trial contacts and locations

1

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Central trial contact

Reyhan Polat

Data sourced from clinicaltrials.gov

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