Back to resultsEffect of Induction Method in Post Operative Agitation
Primary Purpose
Emergence Agitation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mask ventilation
intravenous cannulation
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Agitation
Eligibility Criteria
Inclusion Criteria:
- pediatric adenotonsillectomy
Exclusion Criteria:
- patients with neurological, hepatic, renal disorders and using any drugs
Sites / Locations
- Dışkapı Yıldırım Beyazıt Education and research hospital
- Ahi evran university education and research hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
mask ventilation
intravenous induction
Arm Description
induction is made with mask ventilation
induction is made with intravenous cannulation
Outcomes
Primary Outcome Measures
assess changing in pediatric agitation/ emergence delirium scale(PAED) scores
to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.
Secondary Outcome Measures
FLACC (face, legs,activity, cry, consolobility)
to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit
Full Information
NCT ID
NCT03252405
First Posted
August 8, 2017
Last Updated
September 30, 2019
Sponsor
Ahi Evran University Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03252405
Brief Title
Effect of Induction Method in Post Operative Agitation
Official Title
the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy
Detailed Description
Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mask ventilation
Arm Type
Active Comparator
Arm Description
induction is made with mask ventilation
Arm Title
intravenous induction
Arm Type
Experimental
Arm Description
induction is made with intravenous cannulation
Intervention Type
Device
Intervention Name(s)
mask ventilation
Other Intervention Name(s)
induction method with mask ventilation
Intervention Description
before intravenous induction, mask application is made. then intravenous cannulation and induction
Intervention Type
Device
Intervention Name(s)
intravenous cannulation
Other Intervention Name(s)
induction method with intravenous cannulation
Intervention Description
induction is applied by using intravenous cannulation
Primary Outcome Measure Information:
Title
assess changing in pediatric agitation/ emergence delirium scale(PAED) scores
Description
to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.
Time Frame
postoperative first hour
Secondary Outcome Measure Information:
Title
FLACC (face, legs,activity, cry, consolobility)
Description
to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit
Time Frame
postoperative first hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pediatric adenotonsillectomy
Exclusion Criteria:
patients with neurological, hepatic, renal disorders and using any drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kevser peker
Organizational Affiliation
Ahi Evran University Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dışkapı Yıldırım Beyazıt Education and research hospital
City
Ankara
Country
Turkey
Facility Name
Ahi evran university education and research hospital
City
Kırşehir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32048203
Citation
Peker K, Polat R. Effects of intravenous and mask induction on post-operative emergence delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Ir J Med Sci. 2020 Aug;189(3):1061-1068. doi: 10.1007/s11845-020-02197-4. Epub 2020 Feb 11.
Results Reference
derived
Learn more about this trial
Effect of Induction Method in Post Operative Agitation
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