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Local Anesthesia and Tuberculin Skin Test in Infants and Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00309673
First received: March 31, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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:


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: 60
  Eligibility

Ages Eligible for Study:   1 Month to 15 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Robert Debré Hospital
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nicole Beydon, MD APHP
  More Information

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Lidocaine
EMLA
Prilocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined

ClinicalTrials.gov processed this record on December 06, 2016