Effect of Induction Method in Post Operative Agitation
the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy
1 other identifier
interventional
67
1 country
2
Brief Summary
To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2017
CompletedFirst Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedOctober 2, 2019
September 1, 2019
3 months
August 8, 2017
September 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
postoperative first hour
Secondary Outcomes (1)
FLACC (face, legs,activity, cry, consolobility)
postoperative first hour
Study Arms (2)
mask ventilation
ACTIVE COMPARATORinduction is made with mask ventilation
intravenous induction
EXPERIMENTALinduction is made with intravenous cannulation
Interventions
before intravenous induction, mask application is made. then intravenous cannulation and induction
induction is applied by using intravenous cannulation
Eligibility Criteria
You may qualify if:
- pediatric adenotonsillectomy
You may not qualify if:
- patients with neurological, hepatic, renal disorders and using any drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dışkapı Yıldırım Beyazıt Education and research hospital
Ankara, Turkey (Türkiye)
Ahi evran university education and research hospital
Kırşehir, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 32048203DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
kevser peker
Ahi Evran University Education and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 17, 2017
Study Start
August 2, 2017
Primary Completion
October 30, 2017
Study Completion
October 30, 2017
Last Updated
October 2, 2019
Record last verified: 2019-09