Efficacy of a New Topical Anesthetic

Pain Clinical Trial

Official title:

A Single-blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562211
• Other study ID #: 2465CTIL
• Secondary ID: 2465
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 20, 2007
• Last updated: May 5, 2014
• Start date: November 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2007
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Israel	Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self report assessment of pain (using the Visual Analog Scale)		60 Min+ 5-10 Min	No
Secondary	Medical staff observational assessment of pain (in a scale of 0 to 10)		60 Min + 5-10 Min	No