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Efficacy of a New Topical Anesthetic

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00562211
First received: November 20, 2007
Last updated: April 15, 2008
Last verified: November 2007
History of Changes
  Purpose

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).


Condition Intervention Phase
Pain
 Drug: LidoDyn
Drug: EMLA creme
 Phase 1
Phase 2

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

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Self report assessment of pain (using the Visual Analog Scale) [ Time Frame: 60 Min+ 5-10 Min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical staff observational assessment of pain (in a scale of 0 to 10) [ Time Frame: 60 Min + 5-10 Min ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562211

Locations
Israel
Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Itai Shavit, M.D., Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00562211     History of Changes
Other Study ID Numbers: 2465CTIL, 2465
Study First Received: November 20, 2007
Last Updated: April 15, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
children

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013