Local Anesthesia and Tuberculin Skin Test in Infants and Children

NCT00309673 | Unknown

• 1 other identifier: CRC05001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis

Keywords

tuberculosis, tuberculin, childhood, pain

Outcome Measures

Primary Outcomes (2)

• Measurement of tuberculin skin tests reaction performed with and without

• local anaesthesia, in a child (intra subject reproducibility)

Secondary Outcomes (5)

• 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

Interventions

lidocaine / Prilocaine DRUG

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Tuberculosis; Pain

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Nicole Beydon, MD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Beydon, MD

CONTACT

+33 140 032 000; nicole.beydon@rdb.aphp.fr

Estelle Marcault, ARC

CONTACT

+33 140 256 252; estelle.marcault@bch.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Last Updated: April 3, 2006

Record last verified: 2006-03

Locations

FR (1)