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NCT Number: NCT04085744

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

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.

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Key information

Conditions

Anesthesia Intubation Complication Infections Intubation Complication Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Sore Throat Stomatognathic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health and Science University Derince Training and Research Hospital

Derince, Kocaeli, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine 10% Spray

Drug

lidocaine will be apply on the cuff

Other names: lidocaine

Mometasone nasal spray

Drug

mometasone spray will be applied on the cuff

Other names: steroid

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: LA-STEROID

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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