Efficacy of a New Topical Anesthetic

May 5, 2014 updated by: i_shavit, Rambam Health Care Campus

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: LidoDyn
Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
Active Comparator: 2
Drug: EMLA creme
Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2465CTIL
  • 2465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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