Topical anesthesia of healthy skin before venous or subcutaneous puncture, before superficial cutaneous instrumental surgery or laser beam (tattoo or cutaneousangioma)
Conditions
Interventions
Product Name: Lidocaine 4% cream
Pharmaceutical Form: Cream
INN or Proposed INN: LIDOCAINE
CAS Number: 137586
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration
Sponsors
Merck Sante France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Child 0 to 17 years old. 2. Availability to complete the study. 3. Parents or guardians have voluntarily given written informed consent for the child to participate in the study and comply with the requirements and restrictions listed in the consent form and the Subject Information Document. 4. Child 6 years old and older has voluntarily given written informed assent to participate in the study and comply with the requirements and restrictions listed in the consent form and the Subject Information Document. 5. Parents or guardians are affiliated to French Social Security. 6. Child undergoing surgery ASA stages II and I, requested general anaesthesia. 7. Female subjects in age to procreate have to present a negative pregnancy test (urinary) at the date of cream application. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Premature child. 2. Concurrent therapy with lidocaine and prilocaine 3. Child undergoing surgery ASA stage III to V. 4. The child has participated in a study during the previous month or participates simultaneously in another clinical trial. 5. History of hypersensitivity to lidocaine or prilocaine or any component of the EMLA or 4% lidocaine formulations. 6. G6PD deficiency. 7. Porphyria. 8. Congenial methemoglobinemia. 9. Child taking of medicinal products susceptible to lead to methemoglobinemia, as sulpha drugs, dapsone, metoclopramide, flutamide, nitroprussiate of sodium, in particular infant between 0 to 3 months. 10. In the opinion of the Principal Investigators, presence of other serious or unstable underlying systemic disease, as determined by history, physical examination and screening investigations. 11. The parent/guardian has forfeited his freedom by administrative or legal award, or is under guardianship. 12. Use of local anaesthetics drugs within 24H and during the conduct of the trial (from screening to end of trial). 13. Skin illness, angioma...
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetics of lidocaine from 4% lidocaine cream when applied to the skin of children, as compared to EMLA cream. To evaluate the safety of 4% lidocaine cream (adverse events, local tolerability, maximal exposure), as compared to EMLA cream.;Secondary Objective: To estimate the onset of anesthetic effect after 60 min application of 4% lidocaine cream and EMLA cream during catheter inserted in a vein of the antecubital fossa area or on the hand back on one arm for induction when applicable.;Primary end point(s): Pharmacokinetics will be estimated using sparse sampling design (and analysed by population pharmacokinetics modelling): 3 samples will be collected from children = 7 years; 0,7 to 1mL each to be obtained through indwelling venous cannula or direct venipuncture. The assay lower limit of quantification (LOQ) is 1 ng/mL for a plasma volume of 500 µL. Bioanalytical measurement of lidocaine will be performed at a central laboratory. Sampling times have been selected by time window to optimise parameter estimation and minimise the stress to subjects. | — |
Countries
France
Outcome results
None listed