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Clinical Trials/NCT01125332
NCT01125332
Terminated
Phase 3

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

Assistance Publique Hopitaux De Marseille1 site in 1 country1 target enrollmentFebruary 2010

Overview

Phase
Phase 3
Intervention
Indirect laryngoscopy in the flexible nasofibroscope
Conditions
Nasofibroscopy
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
1
Locations
1
Primary Endpoint
efficacity of local anesthetic
Status
Terminated
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
November 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

group gel KY

Intervention: Indirect laryngoscopy in the flexible nasofibroscope

group gel lidocaine

Intervention: Indirect laryngoscopy in the flexible nasofibroscope

Outcomes

Primary Outcomes

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 Outcomes

  • pain's scale

Study Sites (1)

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