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

Emergence Agitation Clinical Trial

— EDIRA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03426020
• Other study ID #: 27/11/2017 43/20
• Secondary ID: Ministry of Heal
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 12, 2017
• Last updated: February 1, 2018
• Start date: February 20, 2018
• Est. completion date: June 10, 2018

Study information

• Verified date: December 2017
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Reyhan Polat
• Phone: 5326734310
• Email: reyhanp9[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 10, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• ASA I-II

• Pediatric patients

• Elective surgery

• Adenotonsillectomi

Exclusion Criteria:

• Cronicdesease

• Mental retarde

• Hearing and visual impaired

• Prematurite

Related Conditions & MeSH terms

• Delirium
• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Other:
• Oral midazolam
0.5 mg/kg oral midazolam administered 20 minutes before induction
• Film 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.
• Play game (PC fishing game)
Patients will be played a simple PC game (a fishing game) 20 minutes before induction

Locations

Country	Name	City	State
Turkey	Reyhan Polat	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence agitation	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.	Postoperative every 5 minutes for 15 minutes
Secondary	preoperative anxiety	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.	20 minutea after premedications.
Secondary	Post operative pain	Postoperative 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	Postoperative every 5 minutes for 15 minutes
Secondary	Mean arteriel pressure	Mean 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.	Postoperative every 5 minutes for15 minutes
Secondary	Heart rate	Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.	Postoperative every 5 minutes for15 minutes.