Efficacy of a New Topical Anesthetic

R

Rambam Health Care Campus

Status and phase

Completed
Phase 2
Phase 1

Conditions

Pain

Treatments

Drug: EMLA creme
Drug: LidoDyn

Study type

Interventional

Funder types

Other

Identifiers

NCT00562211
2465
2465CTIL

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

12 to 16 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: LidoDyn
2
Active Comparator group
Treatment:
Drug: EMLA creme

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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