NCT03252405

Brief Summary

To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

August 8, 2017

Last Update Submit

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 COMPARATOR

induction is made with mask ventilation

Device: mask ventilationDevice: intravenous cannulation

intravenous induction

EXPERIMENTAL

induction is made with intravenous cannulation

Device: intravenous cannulation

Interventions

before intravenous induction, mask application is made. then intravenous cannulation and induction

Also known as: induction method with mask ventilation
mask ventilation

induction is applied by using intravenous cannulation

Also known as: induction method with intravenous cannulation
intravenous inductionmask ventilation

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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)

Location

Ahi evran university education and research hospital

Kırşehir, Turkey (Türkiye)

Location

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.

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • kevser peker

    Ahi Evran University Education and Research Hospital

    PRINCIPAL INVESTIGATOR

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

Locations