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Local Anesthesia and Tuberculin Skin Test in Infants and Children

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Tuberculosis

Treatments

Drug: lidocaine / Prilocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00309673
CRC05001

Details and patient eligibility

About

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

Sex

All

Ages

1 month to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Estelle Marcault, ARC; Nicole Beydon, MD

Data sourced from clinicaltrials.gov

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