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NCT04085744 Clinical Trial

A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff

Intubation Complication Clinical Trial

— LA-STEROID  

Official title:
A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04085744
Other study ID # AOLC-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date June 15, 2020

Study information
Verified date November 2023
Source Derince Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

In the literature there were studies about both local anesthetic agents and topical steroids and different densities of saline which were applied to decrease airway complications. In this study researchers intended to compare effects of local anesthetic agents and topical steroids applying around tracheal tube on airway complications which may occur in the first 24 hours after surgery. All pediatric patients scheduled for elective surgery will be recruited. enrolled patients will randomly assigned in to three groups: Control group, local anesthetic group and topical steroid group.

Recruitment information / eligibility
Status Completed
Enrollment 91
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - Being ages between 2 and 18 - undergoing elective surgery - intubated patients over 1 hour - ASA(American Society of Anesthesiologists) Class I-II patients Exclusion Criteria: - Urgent surgeries - Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine 10% Spray
lidocaine will be apply on the cuff
• Mometasone nasal spray
mometasone spray will be applied on the cuff

Locations
Country Name City State
Turkey Health and Science University Derince Training and Research Hospital Derince Kocaeli

Sponsors (1)
Lead Sponsor Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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