Pain
Conditions
Keywords
children
Brief summary
A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn). The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème).
Interventions
DRUGLidoDyn
Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
DRUGEMLA creme
Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Previously healthy children of whom venipuncture is needed to be performed.
Exclusion criteria
* History of allergic reaction to any local anesthetic. * History of chronic disease * Patient's condition requires urgent treatment (e.g. severe dehydration, shock) * Active local skin infection or skin pathologic condition at the antecubital fossa * Tattoo, surgical scar or skin condition that might interfere with skin sight assessment. * Patient undergone venipuncture at the antecubital fossa within the pror two weeks. * Uncooperative or exceptionally anxious patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self report assessment of pain (using the Visual Analog Scale) | 60 Min+ 5-10 Min |
Secondary
| Measure | Time frame |
|---|---|
| Medical staff observational assessment of pain (in a scale of 0 to 10) | 60 Min + 5-10 Min |
Countries
Israel
Outcome results
None listed