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OpenTrials
Completed

NCT Number: NCT00562211

Efficacy of a New Topical Anesthetic

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Haifa, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LidoDyn

Drug

Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture

EMLA creme

Drug

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

Primary outcomes

  1. Self report assessment of pain (using the Visual Analog Scale)

    Time frame: 60 Min+ 5-10 Min

Secondary outcomes

  1. Medical staff observational assessment of pain (in a scale of 0 to 10)

    Time frame: 60 Min + 5-10 Min

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2007
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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