Efficacy of a New Topical Anesthetic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

LidoDyn

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

EMLA creme

Intervention Type DRUG

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

Interventions

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LidoDyn

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

Intervention Type DRUG

EMLA creme

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes