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Reduction of Topical Anesthetic Onset Time Using Ultrasound

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126932
First Posted: August 5, 2005
Last Update Posted: December 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Connecticut Children's Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00126932     History of Changes
Other Study ID Numbers: 05-003
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: December 27, 2007
Last Verified: December 2007

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