Efficacy of a New Topical Anesthetic

Rambam Health Care Campus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pain

Treatments: Drug: EMLA creme; Drug: LidoDyn

Study type: Interventional

Funder types: Other

Identifiers

NCT00562211

2465

2465CTIL

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: LidoDyn

2

Active Comparator group

Treatment:

Drug: EMLA creme