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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01125332
First received: May 17, 2010
Last updated: August 29, 2014
Last verified: August 2014

May 17, 2010
August 29, 2014
February 2010
May 2010   (final data collection date for primary outcome measure)
efficacity of local anesthetic [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01125332 on ClinicalTrials.gov Archive Site
pain's scale [ Designated as safety issue: No ]
The child estimates his(her) own pain by postponing her(it) on a scale of more or less painful faces.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Nasofibroscopy
Drug: Indirect laryngoscopy in the flexible nasofibroscope
  • Placebo Comparator: group gel KY
    Intervention: Drug: Indirect laryngoscopy in the flexible nasofibroscope
  • Experimental: group gel lidocaine
    Intervention: Drug: Indirect laryngoscopy in the flexible nasofibroscope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
November 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
4 Years to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01125332
2009 10, 2009-011010-23
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: RICHARD NICOLLAS Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP