Reduction of Topical Anesthetic Onset Time Using Ultrasound

This study has been completed.
Sponsor:
Information provided by:
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00126932
First received: August 3, 2005
Last updated: December 20, 2007
Last verified: December 2007
  Purpose

Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated.


Condition Intervention Phase
Pain
Device: SonoPrep
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction of Topical Anesthetic Onset Time Using Ultrasound: A Randomized Controlled Trial Prior to Venipuncture in Young Children

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • pain associated with venipuncture

Secondary Outcome Measures:
  • safety
  • skin effects
  • tolerability

Estimated Enrollment: 70
Study Start Date: October 2004
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 3-7, requiring venipuncture

Exclusion Criteria:

  • Emergent procedure
  • Allergy to lidocaine or sodium lauryl sulfate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126932

Locations
United States, Connecticut
CT Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: William T. Zempsky, MD CT Children's Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126932     History of Changes
Other Study ID Numbers: 05-003
Study First Received: August 3, 2005
Last Updated: December 20, 2007
Health Authority: United States: Institutional Review Board

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 August 21, 2014