- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00309673
Local Anesthesia and Tuberculin Skin Test in Infants and Children
March 31, 2006 updated by: Assistance Publique - Hôpitaux de Paris
Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children
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
Study Overview
Study Type
Interventional
Enrollment
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole Beydon, MD
- Phone Number: +33 140 032 000
- Email: nicole.beydon@rdb.aphp.fr
Study Contact Backup
- Name: Estelle Marcault, ARC
- Phone Number: +33 140 256 252
- Email: estelle.marcault@bch.aphp.fr
Study Locations
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-
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Paris, France, 75019
- Robert Debre Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Measurement of tuberculin skin tests reaction performed with and without
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local anaesthesia, in a child (intra subject reproducibility)
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Secondary Outcome Measures
Outcome Measure |
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influence of local anaesthesia use, on tuberculin skin test interpretation
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between observer reproducibility
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pain evaluation in child over 5 years of age between tuberculin skin tests performed with and without local anaesthesia
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relationship between local anaesthesia use and failure to perform a correct intradermal injection
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local tolerance to lidocaine / prilocaine
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicole Beydon, MD, APHP
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 31, 2006
First Submitted That Met QC Criteria
March 31, 2006
First Posted (Estimate)
April 3, 2006
Study Record Updates
Last Update Posted (Estimate)
April 3, 2006
Last Update Submitted That Met QC Criteria
March 31, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anesthetics, Combined
- Lidocaine
- Prilocaine
- Lidocaine, Prilocaine Drug Combination
Other Study ID Numbers
- CRC05001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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