Efficacy of a New Topical Anesthetic - Tabular View

Tracking Information

First Received Date ^ICMJE

November 20, 2007

Last Updated Date

April 15, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Self report assessment of pain (using the Visual Analog Scale) [ Time Frame: 60 Min+ 5-10 Min ]

Change History

Complete list of historical versions of study NCT00562211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Medical staff observational assessment of pain (in a scale of 0 to 10) [ Time Frame: 60 Min + 5-10 Min ]

Descriptive Information

Brief Title ^ICMJE

Efficacy of a New Topical Anesthetic

Official Title ^ICMJE

A Single-Blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in 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).

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: LidoDyn
Drug: EMLA creme

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 16 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00562211

Responsible Party

Itai Shavit, M.D., Rambam Health Care Campus

Study ID Numbers ^ICMJE

2465CTIL, 2465

Study Sponsor ^ICMJE

Rambam Health Care Campus

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Rambam Health Care Campus

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP