A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff
LA-STEROID
A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients
1 other identifier
interventional
91
1 country
1
Brief Summary
This study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications.
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 Nov 2019
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
September 7, 2019
CompletedFirst Posted
Study publicly available on registry
September 11, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2020
CompletedNovember 18, 2023
November 1, 2023
8 months
September 7, 2019
November 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Visual analog scale (VAS) for pain
Self Reported VAS at postoperative unit. VAS 0 is no pain VAS 10 is pain as bad as can be
1 hour
Visual analog scale (VAS) for pain
Self reported VAS postoperative at hour 6. VAS 0 is no pain VAS 10 is pain as bad as can be
6 hours
Visual analog scale (VAS) for pain
Self reported VAS postoperative at hour 12. VAS 0 is no pain VAS 10 is pain as bad as can be
12 hours
Visual analog scale (VAS) for pain
Self reported VAS at postoperative hour 24. VAS 0 is no pain VAS 10 is pain as bad as can be
24 hours
Study Arms (3)
control group
NO INTERVENTIONIn this group any drug will be applied on the cuff of the intubation tube
lidocaine group
ACTIVE COMPARATOR10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
steroid group
ACTIVE COMPARATORmometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
Interventions
mometasone spray will be applied on the cuff
Eligibility Criteria
You may qualify if:
- Being ages between 2 and 18
- undergoing elective surgery
- intubated patients over 1 hour
- ASA(American Society of Anesthesiologists) Class I-II patients
You may not qualify if:
- Urgent surgeries
- Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health and Science University Derince Training and Research Hospital
Derince, Kocaeli, 41900, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ayse Z Turan
HEALTH AND SCİENCE UNIVERSITY DERINCE TRAINING AND RESEARCH HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 7, 2019
First Posted
September 11, 2019
Study Start
November 1, 2019
Primary Completion
June 15, 2020
Study Completion
June 15, 2020
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share