Local Anesthesia and Tuberculin Skin Test in Infants and Children

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00309673
• Other study ID #: CRC05001
• Status: Not yet recruiting
• Phase: N/A
• First received: March 31, 2006
• Last updated: March 31, 2006

Study information

• Verified date: March 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nicole Beydon, MD
• Phone: +33 140 032 000
• Email: nicole.beydon[@]rdb.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 15 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• lidocaine / Prilocaine

Locations

Country	Name	City	State
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of tuberculin skin tests reaction performed with and without
Primary	local anaesthesia, in a child (intra subject reproducibility)
Secondary	influence of local anaesthesia use, on tuberculin skin test interpretation
Secondary	between observer reproducibility
Secondary	pain evaluation in child over 5 years of age between tuberculin skin tests performed with and without local anaesthesia
Secondary	relationship between local anaesthesia use and failure to perform a correct intradermal injection
Secondary	local tolerance to lidocaine / prilocaine