Efficacy of a New Topical Anesthetic

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: EMLA creme; Drug: LidoDyn

• Registration Number: NCT00562211
• Lead Sponsor: Rambam Health Care Campus

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 available

Study Timeline

• Status Verified: 2007-11
• Study Start: 2007-11
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	EMLA creme	-
1	LidoDyn	-

Primary Outcome Measures

Name	Time	Method
Self report assessment of pain (using the Visual Analog Scale)	60 Min+ 5-10 Min

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus; 🇮🇱 Haifa, Israel