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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01125332
Enrollment
1
Registered
2010-05-18
Start date
2010-02-28
Completion date
2010-11-30
Last updated
2014-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasofibroscopy

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.

Interventions

DRUGIndirect laryngoscopy in the flexible nasofibroscope

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
efficacity of local anestheticThe 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

MeasureTime frameDescription
pain's scaleThe child estimates his(her) own pain by postponing her(it) on a scale of more or less painful faces.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026