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Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126919
First Posted: August 5, 2005
Last Update Posted: February 9, 2012
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 (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center
  Purpose
Children ages 3-17 who are undergoing port access receive both standard care, topical medicine for numbing (LMX4), and the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The procedures will be performed on 2 separate visits to the clinic. The child's pain with the access procedure is evaluated.

Condition Intervention Phase
Pain Device: SonoPrep Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Crossover Trial of Sonication Followed by 5 Minute LMX4 Application Compared With 30 Minute LMX4 Application for Topical Anesthesia Prior to Subcutaneous Port Access in Children

Further study details as provided by William Zempsky, MD, Connecticut Children's Medical Center:

Primary Outcome Measures:
  • pain

Secondary Outcome Measures:
  • tolerability
  • safety-skin effects

Estimated Enrollment: 40
Study Start Date: October 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 3-17 with subcutaneous port

Exclusion Criteria:

  • Emergent need for port access
  • Allergy to lidocaine 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): NCT00126919


Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06040
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: William T. Zempsky, MD CT Children's Medical Center
  More Information

Responsible Party: William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00126919     History of Changes
Other Study ID Numbers: 05-002
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: February 9, 2012
Last Verified: February 2012