TuberculosisNCT00309673
Local Anesthesia and Tuberculin Skin Test in Infants and Children
A study testing lidocaine / Prilocaine in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- lidocaine / Prilocaine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- -
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children
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
- Being tested
- lidocaine / Prilocaine
- Keywords
- tuberculosis, tuberculin, childhood, pain
- Medical subject headings
- Tuberculosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine / PrilocaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Nicole Beydon, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309673
- Sponsor's protocol ID
- CRC05001
- Status last verified
- Mar 2006
- First submitted
- 31 Mar 2006
- Last updated
- 3 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children
- ClinicalTrials.gov ID
- NCT00309673
- Acronym / sponsor ID
- CRC05001
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, tuberculin, childhood, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine / Prilocaine | Drug | – |
Primary outcome
Measurement of tuberculin skin tests reaction performed with and without
local anaesthesia, in a child (intra subject reproducibility)
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Beydon, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine / Prilocaine in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Beydon, MD (+33 140 032 000, nicole.beydon@rdb.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of tuberculin skin tests reaction performed with and without. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2006.