Local Anesthesia and Tuberculin Skin Test in Infants and Children

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2006 by Assistance Publique - Hôpitaux de Paris. Recruitment status was Not yet recruiting

First Received on March 31, 2006. No Changes Posted

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00309673

Purpose

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	Intervention
Tuberculosis	Drug: lidocaine / Prilocaine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Tuberculin Purified Protein Derivative Lidocaine Prilocaine Prilocaine hydrochloride

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	1 Month to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309673

Contacts

Contact: Nicole Beydon, MD	+33 140 032 000	nicole.beydon@rdb.aphp.fr
Contact: Estelle Marcault, ARC	+33 140 256 252	estelle.marcault@bch.aphp.fr

Locations

France
Robert Debré Hospital	Active, not recruiting
Paris, France, 75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Nicole Beydon, MD

APHP

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00309673 History of Changes
Other Study ID Numbers:	CRC05001
Study First Received:	March 31, 2006
Last Updated:	March 31, 2006
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:

tuberculosis, tuberculin, childhood, pain

Additional relevant MeSH terms:

Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anesthetics
Prilocaine
Lidocaine
EMLA
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Combined

ClinicalTrials.gov processed this record on February 09, 2012