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

August 29, 2014 updated by: Assistance Publique Hopitaux De Marseille

Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Assisatnce Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group gel KY
Drug: Indirect laryngoscopy in the flexible nasofibroscope
Experimental: group gel lidocaine
Drug: Indirect laryngoscopy in the flexible nasofibroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: RICHARD NICOLLAS, Assistance Publique Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 18, 2010

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2009 10
  • 2009-011010-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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