Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT03426020
Status:
UNKNOWN
Last Update Posted:
2018-02-08
First Post:
2017-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium
Sponsor:
Diskapi Yildirim Beyazit Education and Research Hospital
Organization:
Study Overview
Official Title:
The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EDIRA
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Ministry of Health | OTHER | Diskapi Yildirim Beyazit Education and Research Hospital | View |