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Clinical Trials/NCT03426020
NCT03426020
Unknown
Phase 4

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

Diskapi Yildirim Beyazit Education and Research Hospital1 site in 1 country90 target enrollmentFebruary 20, 2018

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Emergence Agitation
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Enrollment
90
Locations
1
Primary Endpoint
Emergence agitation
Last Updated
8 years ago

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" 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.

Registry
clinicaltrials.gov
Start Date
February 20, 2018
End Date
June 10, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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

Reyhan Polat

Associate Profesor

Diskapi Yildirim Beyazit Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients
  • Elective surgery
  • Adenotonsillectomi

Exclusion Criteria

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

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.)

Study Sites (1)

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