Local Anesthesia and Tuberculin Skin Test in Infants and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309673
Recruitment Status : Unknown
Verified March 2006 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : April 3, 2006
Last Update Posted : April 3, 2006
Information provided by:
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: lidocaine / Prilocaine Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children

Primary Outcome Measures :
  1. Measurement of tuberculin skin tests reaction performed with and without
  2. local anaesthesia, in a child (intra subject reproducibility)

Secondary Outcome Measures :
  1. influence of local anaesthesia use, on tuberculin skin test interpretation
  2. between observer reproducibility
  3. pain evaluation in child over 5 years of age between tuberculin skin tests performed with and without local anaesthesia
  4. relationship between local anaesthesia use and failure to perform a correct intradermal injection
  5. local tolerance to lidocaine / prilocaine

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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309673

Contact: Nicole Beydon, MD +33 140 032 000
Contact: Estelle Marcault, ARC +33 140 256 252

Robert Debré Hospital Active, not recruiting
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Nicole Beydon, MD APHP Identifier: NCT00309673     History of Changes
Other Study ID Numbers: CRC05001
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: March 2006

Keywords provided by Assistance Publique - Hôpitaux de Paris:
tuberculosis, tuberculin, childhood, pain

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined