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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anesthesia Intubation Complication, Intubation Complication, Sore Throat

Intervention / Treatment
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* Drug: Lidocaine 10% Spray
* Drug: Mometasone nasal spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, anesthesia, corticosteroids, lidocaine, complication of intubation