A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff (LA-STEROID)

November 17, 2023 updated by: ALI ULVI OLC, Derince Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kocaeli
      • Derince, Kocaeli, Turkey, 41900
        • Health and Science University Derince Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
In this group any drug will be applied on the cuff of the intubation tube
Active Comparator: lidocaine group
10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
Drug: Lidocaine 10% Spray
lidocaine will be apply on the cuff
Other Names:
  • lidocaine
Active Comparator: steroid group
mometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
Drug: Mometasone nasal spray
mometasone spray will be applied on the cuff
Other Names:
  • steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS) for pain
Time Frame: 1 hour
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
Time Frame: 6 hours
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
Time Frame: 12 hours
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
Time Frame: 24 hours
Self reported VAS at postoperative hour 24. VAS 0 is no pain VAS 10 is pain as bad as can be
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Investigators

  • Study Director: Ayse Z Turan, Health and Science University Derince Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

September 7, 2019

First Submitted That Met QC Criteria

September 7, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOLC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intubation Complication

Clinical Trials on Lidocaine 10% Spray

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe