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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Terminated
Phase 3

Conditions

Nasofibroscopy

Treatments

Drug: Indirect laryngoscopy in the flexible nasofibroscope

Study type

Interventional

Funder types

Other

Identifiers

NCT01125332
2009-011010-23 (EudraCT Number)
2009 10

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

4 to 7 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1 participants in 2 patient groups, including a placebo group

group gel KY
Placebo Comparator group
Treatment:
Drug: Indirect laryngoscopy in the flexible nasofibroscope
Drug: Indirect laryngoscopy in the flexible nasofibroscope
group gel lidocaine
Experimental group
Treatment:
Drug: Indirect laryngoscopy in the flexible nasofibroscope
Drug: Indirect laryngoscopy in the flexible nasofibroscope

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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