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Clinical Trials/NCT03426020
NCT03426020UnknownPhase 4

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

Diskapi Yildirim Beyazit Education and Research Hospital2 sites in 1 country90 target enrollmentStarted: February 20, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
Emergence agitation

Study Overview

Brief Summary

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

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"

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
2 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pediatric patients
  • Elective surgery
  • Adenotonsillectomi

Exclusion Criteria

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

Arms & Interventions

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

Active Comparator

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).

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

Play game (PC fishing game)

Active Comparator

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).

Intervention: Play game (PC fishing game) (Other)

Oral midazolam (Demizolam®)

Active Comparator

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).

Intervention: Oral midazolam (Other)

Outcomes

Primary Outcomes

Emergence agitation

Time Frame: Postoperative every 5 minutes for 15 minutes

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.

Secondary Outcomes

  • preoperative anxiety(20 minutea after premedications.)
  • Post operative pain(Postoperative every 5 minutes for 15 minutes)
  • Mean arteriel pressure(Postoperative every 5 minutes for15 minutes)
  • Heart rate(Postoperative every 5 minutes for15 minutes.)

Investigators

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Reyhan Polat

Associate Profesor

Diskapi Yildirim Beyazit Education and Research Hospital

Study Sites (2)

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