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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Intubation Complication
• Pharyngitis
• Sore Throat

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