Efficacy of a New Topical Anesthetic - Full Text View

Sponsor:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00562211

Purpose

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).

Condition	Intervention	Phase
Pain	Drug: LidoDyn Drug: EMLA creme	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

Self report assessment of pain (using the Visual Analog Scale) [ Time Frame: 60 Min+ 5-10 Min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Medical staff observational assessment of pain (in a scale of 0 to 10) [ Time Frame: 60 Min + 5-10 Min ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: LidoDyn Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
2: Active Comparator	Drug: EMLA creme Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture

Eligibility

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562211

Locations

Israel
Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus
Haifa, Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

More Information

No publications provided

Responsible Party:	Rambam Health Care Campus ( Itai Shavit, M.D. )
Study ID Numbers:	2465CTIL, 2465
Study First Received:	November 20, 2007
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00562211 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

children

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009