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Local Anesthesia and Tuberculin Skin Test in Infants and Children

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tuberculosis

Intervention: lidocaine / Prilocaine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Nicole Beydon, MD, Principal Investigator, Affiliation: APHP

Overall contact:
Nicole Beydon, MD, Phone: +33 140 032 000, Email: nicole.beydon@rdb.aphp.fr

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

Clinical Details

Official title: Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome:

Measurement of tuberculin skin tests reaction performed with and without

local anaesthesia, in a child (intra subject reproducibility)

Secondary outcome:

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

Eligibility

Minimum age: 1 Month. Maximum age: 15 Years. Gender(s): Both.

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

Locations and Contacts

Nicole Beydon, MD, Phone: +33 140 032 000, Email: nicole.beydon@rdb.aphp.fr

Robert Debré Hospital, Paris 75019, France; Active, not recruiting
Additional Information


Last updated: March 31, 2006

Page last updated: August 23, 2015

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