Efficacy of a New Topical Anesthetic | NCT00562211

Studies
Efficacy of a New Topical Anesthetic

NCT00562211

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

May 6, 2014Estimated

Enrollment

40Actual

Phase

Phase 1Phase 2

Conditions

Pain

Interventions

LidoDyn
EMLA creme

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2465

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Nov 20, 2007

First Posted Date

Nov 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2014

Last Update Posted Date

May 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

i_shavit, Pediatric Emergency Department director, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: LidoDyn
2	Active Comparator		Drug: EMLA creme

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LidoDyn	Drug	Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided