NCT00562211

CompletedPhase 1/2

Efficacy of a New Topical Anesthetic

Rambam Health Care Campus Source

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Other study identifiers

Sponsor study identifier

2465CTIL

Secondary identifiers

2465

Study Type

interventional

Actual enrollment (reported)

40

Locations

1 country

Sites

1

Timeline

Study Start

November 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2008

Actual (reported)

Study Completion

April 2008

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 40 participants
Study completion date: April 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 20, 2007
Actual (reported)
First Posted
November 21, 2007
Actual (reported)
Primary Completion
April 2008
Actual (reported)
Study Completion
April 2008
Actual (reported)

Last Updated: May 6, 2014
Status Verified: November 2007
Last Update Submitted: May 5, 2014

Conditions

Pain

Keywords

children

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

EXPERIMENTAL

Drug: LidoDyn

2

ACTIVE COMPARATOR

Drug: EMLA creme

Interventions

LidoDynDrug

Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture

1

EMLA cremeDrug

Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years - 16 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Previously healthy children of whom venipuncture is needed to be performed.

You may not qualify if:

Sponsors & Collaborators

Rambam Health Care Campus
Otherlead

Study Sites (1)

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

Haifa, Israel

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

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
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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 2007

Date type not reported

This date has not been verified as actual or estimated.

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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.

Primary Completion

April 2008

Actual (reported)

Study Completion

April 2008

Actual (reported)

Last Updated

May 6, 2014

Record last verified: 2007-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00562211
Data provider: ClinicalTrials.gov
Source updated: 2014-05-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:50 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations