Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

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. Identifier: NCT00126919
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Device: SonoPrep Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Primary Outcome Measures :
  1. pain

Secondary Outcome Measures :
  1. tolerability
  2. safety-skin effects

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

Inclusion Criteria:

  • Children ages 3-17 with subcutaneous port

Exclusion Criteria:

  • Emergent need for port access
  • Allergy to lidocaine sodium lauryl sulfate

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 identifier (NCT number): NCT00126919

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

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