Efficacy of a New Topical Anesthetic
Information source: Rambam Health Care Campus
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: LidoDyn (Drug); EMLA creme (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s):
Itai Shavit, M.D., Principal Investigator, Affiliation: Rambam Health Care Campus
Hadas Knaani-Levinz, M.D., Principal Investigator, Affiliation: Rambam Health Care Campus
Amir Hadash, M.D., Principal Investigator, Affiliation: Rambam Health Care Campus
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).
Clinical Details
Official title: A Single-Blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.
Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Self report assessment of pain (using the Visual Analog Scale)
Secondary outcome: Medical staff observational assessment of pain (in a scale of 0 to 10)
Eligibility
Minimum age: 12 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus, Haifa, Israel
Additional Information
Starting date: November 2007
Ending date: April 2008
Last updated: April 15, 2008
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