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

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03426020
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
3.6
Anticipated Duration (Months)
24.9
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Other: Oral midazolam
  • Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
  • Other: Play game (PC fishing game)
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Effect of pharmacologic or nonpharmacologic premedication on emergency agitationEffect of pharmacologic or nonpharmacologic premedication on emergency agitation
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients
Anticipated Study Start Date :
Feb 20, 2018
Anticipated Primary Completion Date :
May 30, 2018
Anticipated Study Completion Date :
Jun 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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).

Other: Oral midazolam
0.5 mg/kg oral midazolam administered 20 minutes before induction
Other Names:
  • Demizolam

    		•
    Active Comparator: 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).

    Other: 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.
    Active Comparator: 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).

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

    Outcome Measures

    Primary Outcome Measures

    1. Emergence agitation [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 Outcome Measures

    1. preoperative anxiety [20 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.

    2. Post operative pain [Postoperative every 5 minutes for 15 minutes]

      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

    3. Mean arteriel pressure [Postoperative every 5 minutes for15 minutes]

      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.

    4. Heart rate [Postoperative 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA I-II

    • Pediatric patients

    • Elective surgery

    • Adenotonsillectomi

    Exclusion Criteria:

    • Cronicdesease

    • Mental retarde

    • Hearing and visual impaired

    • Prematurite

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reyhan Polat Ankara Turkey 06610

    Sponsors and Collaborators

    • Diskapi Yildirim Beyazit Education and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reyhan Polat, Associate Profesor, Diskapi Yildirim Beyazit Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03426020
    Other Study ID Numbers:
    • 27/11/2017 43/20
    • Ministry of Health
    First Posted:
    Feb 8, 2018
    Last Update Posted:
    Feb 8, 2018
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Reyhan Polat, Associate Profesor, Diskapi Yildirim Beyazit Education and Research Hospital
    Premedication
    Pediatric patients
    Emergence agitation
    Additional relevant MeSH terms:
    Delirium
    Psychomotor Agitation
    Emergence Delirium
    Midazolam

    Study Results

    No Results Posted as of Feb 8, 2018