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

Phase 3

Terminated

• Conditions: Nasofibroscopy
• Interventions: Drug: Indirect laryngoscopy in the flexible nasofibroscope

• Registration Number: NCT01125332
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-05
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Study Completion: 2010-11
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group gel KY	Indirect laryngoscopy in the flexible nasofibroscope	-
group gel lidocaine	Indirect laryngoscopy in the flexible nasofibroscope	-

Primary Outcome Measures

Name	Time	Method
efficacity of local anesthetic		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.

Secondary Outcome Measures

Name	Time	Method
pain's scale		The child estimates his(her) own pain by postponing her(it) on a scale of more or less painful faces.

Trial Locations

Locations (1)

Assisatnce Publique Hopitaux de Marseille; 🇫🇷 Marseille, France