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

November 20, 2007
April 15, 2008
November 2007
April 2008   (final data collection date for primary outcome measure)
Self report assessment of pain (using the Visual Analog Scale) [ Time Frame: 60 Min+ 5-10 Min ] [ Designated as safety issue: No ]
Self report assessment of pain (using the Visual Analog Scale) [ Time Frame: 60 Min+ 5-10 Min ]
Complete list of historical versions of study NCT00562211 on ClinicalTrials.gov Archive Site
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 ]
Medical staff observational assessment of pain (in a scale of 0 to 10) [ Time Frame: 60 Min + 5-10 Min ]
Not Provided
Not Provided
 
Efficacy of a New Topical Anesthetic
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).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pain
  • Drug: LidoDyn
    Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
  • Drug: EMLA creme
    Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
  • Experimental: 1
    Intervention: Drug: LidoDyn
  • Active Comparator: 2
    Intervention: Drug: EMLA creme
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
12 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00562211
2465CTIL, 2465
No
Itai Shavit, M.D., Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
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
Rambam Health Care Campus
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP