Efficacy of a New Topical Anesthetic
A Single-blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.
2 other identifiers
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pain
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedMay 6, 2014
November 1, 2007
5 months
November 20, 2007
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self report assessment of pain (using the Visual Analog Scale)
60 Min+ 5-10 Min
Secondary Outcomes (1)
Medical staff observational assessment of pain (in a scale of 0 to 10)
60 Min + 5-10 Min
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
Eligibility Criteria
You may qualify if:
- Previously healthy children of whom venipuncture is needed to be performed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Itai Shavit, M.D.
Rambam Health Care Campus
- PRINCIPAL INVESTIGATOR
Hadas Knaani-Levinz, M.D.
Rambam Health Care Campus
- PRINCIPAL INVESTIGATOR
Amir Hadash, M.D.
Rambam Health Care Campus
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Emergency Department director
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 21, 2007
Study Start
November 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
May 6, 2014
Record last verified: 2007-11