Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric Ear Nose Throat (ENT)Consultation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.

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Detailed Description

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Conditions

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Nasofibroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group gel KY

Group Type PLACEBO_COMPARATOR

Indirect laryngoscopy in the flexible nasofibroscope

Intervention Type DRUG

group gel lidocaine

Group Type EXPERIMENTAL

Indirect laryngoscopy in the flexible nasofibroscope

Intervention Type DRUG

Interventions

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Indirect laryngoscopy in the flexible nasofibroscope

Intervention Type DRUG

Indirect laryngoscopy in the flexible nasofibroscope

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects from 4 to 7 years old (old enough to answer the test of self-assessment, the scale of faces)
* Appearing at the consultation of pediatric ENT, requiring an indirect laryngoscopy in the naso-fiberscope for a laryngeal evaluation.
* Subjects girls or boys

Exclusion Criteria

* All the criteria dissuading the employment of a local anesthetic
* Naso-fibroscopie realized within the framework of a nasal obstruction, or of a balance sheet of the gulp.
* Patients having already been examined by naso-fiberscopy, so that their reactions and their answers are not influenced by the previous experience of the examination.
* Not consent of one of both holders of the parental authority

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No