The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients
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
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)
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®)
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
Reyhan Polat
Associate Profesor
Diskapi Yildirim Beyazit Education and Research Hospital