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

Nasofibroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01125332
• Other study ID #: 2009 10
• Secondary ID: 2009-011010-23
• Status: Terminated
• Phase: Phase 3
• First received: May 17, 2010
• Last updated: August 29, 2014
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasofibroscopy

Intervention

Drug:
• Indirect laryngoscopy in the flexible nasofibroscope

• Indirect laryngoscopy in the flexible nasofibroscope

Locations

Country	Name	City	State
France	Assisatnce Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	pain's scale	The child estimates his(her) own pain by postponing her(it) on a scale of more or less painful faces.		No