MedDataX Logo

Local Anesthesia and Tuberculin Skin Test in Infants and Children

NCT ID: NCT00309673

Last Updated: 2006-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lidocaine / Prilocaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicole Beydon, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Robert Debré Hospital

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicole Beydon, MD

Role: CONTACT

[email protected]
+33 140 032 000

Estelle Marcault, ARC

Role: CONTACT

[email protected]
+33 140 256 252

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRC05001

Identifier Type: -

Identifier Source: org_study_id