Back to resultsLocal Anesthesia and Tuberculin Skin Test in Infants and Children
Primary Purpose
Tuberculosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
lidocaine / Prilocaine
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring tuberculosis, tuberculin, childhood, pain
Eligibility Criteria
Inclusion Criteria: hospitalized or non hospitalized infant or child (3 months-15 years)requiring a tuberculin skin test, in our hospital. hospitalized 1 to 3 months old infants requiring a tuberculin skin test, in our hospital. - Exclusion Criteria: child with contra indication to the use of Lidocaine / prilocaine child with evolutive dermatitis on forearms premature or newborn (less than 1 month of age) infants (1 - 24 months of age)who has yet received repeated local anaesthesia (at least 2)during the 24 previous hours infants (1 - 24 months of age)who is treated with a drug that could enhance the risk of methhaemoglobinemia child with previous evere local reaction to tuberculin injection (necrosis,ulceration) child with history of tuberculosis disease child with hepatic failure parents or the child himself if lod enough, have not given their agreement for the study
Sites / Locations
- Robert Debré Hospital
Outcomes
Primary Outcome Measures
Measurement of tuberculin skin tests reaction performed with and without
local anaesthesia, in a child (intra subject reproducibility)
Secondary Outcome Measures
influence of local anaesthesia use, on tuberculin skin test interpretation
between observer reproducibility
pain evaluation in child over 5 years of age between tuberculin skin tests performed with and without local anaesthesia
relationship between local anaesthesia use and failure to perform a correct intradermal injection
local tolerance to lidocaine / prilocaine
Full Information
NCT ID
NCT00309673
First Posted
March 31, 2006
Last Updated
March 31, 2006
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00309673
Brief Title
Local Anesthesia and Tuberculin Skin Test in Infants and Children
Official Title
Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
5. Study Description
Brief Summary
The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when tuberculin skin test is performed it is the skin reaction to tuberculin injection that is studied. It is a quantitative skin reaction measured in millimiters. From the study of literature it is not known whether local anaesthetic modify skin reaction to tuberculin. Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection we have to rule out a potential effect of local anaesthetic on the result of the test. This is particularly important in children, since there are more sensitive to pain than adults
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
tuberculosis, tuberculin, childhood, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
lidocaine / Prilocaine
Primary Outcome Measure Information:
Title
Measurement of tuberculin skin tests reaction performed with and without
Title
local anaesthesia, in a child (intra subject reproducibility)
Secondary Outcome Measure Information:
Title
influence of local anaesthesia use, on tuberculin skin test interpretation
Title
between observer reproducibility
Title
pain evaluation in child over 5 years of age between tuberculin skin tests performed with and without local anaesthesia
Title
relationship between local anaesthesia use and failure to perform a correct intradermal injection
Title
local tolerance to lidocaine / prilocaine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hospitalized or non hospitalized infant or child (3 months-15 years)requiring a tuberculin skin test, in our hospital. hospitalized 1 to 3 months old infants requiring a tuberculin skin test, in our hospital.
-
Exclusion Criteria:
child with contra indication to the use of Lidocaine / prilocaine
child with evolutive dermatitis on forearms
premature or newborn (less than 1 month of age)
infants (1 - 24 months of age)who has yet received repeated local anaesthesia (at least 2)during the 24 previous hours
infants (1 - 24 months of age)who is treated with a drug that could enhance the risk of methhaemoglobinemia
child with previous evere local reaction to tuberculin injection (necrosis,ulceration)
child with history of tuberculosis disease
child with hepatic failure
parents or the child himself if lod enough, have not given their agreement for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Beydon, MD
Phone
+33 140 032 000
Email
nicole.beydon@rdb.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle Marcault, ARC
Phone
+33 140 256 252
Email
estelle.marcault@bch.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Beydon, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Debré Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Local Anesthesia and Tuberculin Skin Test in Infants and Children
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