Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery

Study Overview
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Brief Summary
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The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.

Official Title
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Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial

Conditions
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Anesthesia Intubation Complication

Intervention / Treatment
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* Device: Endotracheal tube
* Device: Nelaton catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years physical status American society of Anesthesiologist(ASA) I orII Exclusion Criteria: History of recurrent epistaxis Coagulopathy Previous nasal surgery History of nasal trauma Severe renal , hepatic or cardiovascular disease History of drug allergy to the drugs used in the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 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
Interventional Model Description: assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Endotracheal tube plus Nelaton catheter | Device: Endotracheal tube<br>* Nasotracheal intubation will be done with endotracheal tube<br>Device: Nelaton catheter<br>* plus nelaton catheter<br>* Other names: Stent;|
| Active Comparator: Group II<br>Endotracheal tube | Device: Endotracheal tube<br>* Nasotracheal intubation will be done with endotracheal tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and severity of Epistaxis | An independent anesthesiologist who did not observe the tube insertion will assess the incidence and severity of epistaxis using a laryngoscope immediately after tube passage through the nasal cavity , four grades to evaluate epistaxis 1- no epistaxis 2- mild epistaxis ,blood apparent on the surface of the tube 3-moderate epistaxis pooling of blood on the posterior pharyngeal wall 4- severe epistaxis , large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation. | immediately after nasotracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathology of the endotracheal tube contents after extubation | after extubation the tube contents will be collected in a 5 ml syringe by using sterile swab then tissues will be separated and will be sent for histopathology , the remnant contents will be sent for microscopy , grading the contents as follow 1- secretions only 2- secretions plus blood 3- secretions , blood plus tissues . | immediately after extubation |