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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01125332
First received: May 17, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Nasofibroscopy
Drug: Indirect laryngoscopy in the flexible nasofibroscope
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: group gel KY Drug: Indirect laryngoscopy in the flexible nasofibroscope
Experimental: group gel lidocaine Drug: Indirect laryngoscopy in the flexible nasofibroscope

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125332

Contacts
Contact: richard NICOLLAS 04 91 38 52 10 richard.nicollas@ap-hm.fr

Locations
France
Assisatnce Publique Hopitaux de Marseille Recruiting
Marseille, France
Contact: RICHARD NICOLLAS         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: RICHARD NICOLLAS Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: direction de la recherche, Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01125332     History of Changes
Other Study ID Numbers: 2009 10, 2009-011010-23
Study First Received: May 17, 2010
Last Updated: May 17, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014