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Efficacy of a New Topical Anesthetic

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ClinicalTrials.gov Identifier: NCT00562211
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
i_shavit, 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).


Condition or disease Intervention/treatment Phase
Pain Drug: LidoDyn Drug: EMLA creme Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : November 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Self report assessment of pain (using the Visual Analog Scale) [ Time Frame: 60 Min+ 5-10 Min ]

Secondary Outcome Measures :
  1. Medical staff observational assessment of pain (in a scale of 0 to 10) [ Time Frame: 60 Min + 5-10 Min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: i_shavit, Pediatric Emergency Department director, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00562211     History of Changes
Other Study ID Numbers: 2465CTIL
2465
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: November 2007

Keywords provided by i_shavit, Rambam Health Care Campus:
children

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs