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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03426020
Acronym
EDIRA
Enrollment
90
Registered
2018-02-08
Start date
2018-02-20
Completion date
2018-06-10
Last updated
2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

Keywords

Premedication, Pediatric patients, Emergence agitation

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.

Interventions

0.5 mg/kg oral midazolam administered 20 minutes before induction

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

patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.

OTHERPlay game (PC fishing game)

Patients will be played a simple PC game (a fishing game) 20 minutes before induction

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

Effect of pharmacologic or nonpharmacologic premedication on emergency agitation

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Emergence agitationPostoperative every 5 minutes for 15 minutesEmergence 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

MeasureTime frameDescription
preoperative anxiety20 minutea after premedications.Preoperative anxiety will be evaluated by Modified Yale Preoperative Anxiety Scale ( m-YPAS )scores. Range between 23 to 100. m-YPAS score above 30 is significant to patients anxiety.
Post operative painPostoperative every 5 minutes for 15 minutesPostoperative pain will be evaluated by behavioral pain scale FLACC(behavioral pain assesment scale). Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0 = Relaxed and comfortable. 1 - 3 = mild discomfort 4 - 6 = moderate pain 7 - 10 = Severe discomfort or pain or both
Mean arteriel pressurePostoperative every 5 minutes for15 minutesMean arteriel pressure, will be measured. Mean blood pressurre range between 66 to 73 mm Hg is considered normal value. 20% increase in baseline value is considered significant.
Heart ratePostoperative every 5 minutes for15 minutes.Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.

Countries

Turkey (Türkiye)

Contacts

Primary ContactReyhan Polat
reyhanp9@gmail.com5326734310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026