Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

This study has been completed.

First Received on August 3, 2005. Last Updated on February 8, 2012 History of Changes

Sponsor:	Connecticut Children's Medical Center
Information provided by (Responsible Party):	William Zempsky, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:	NCT00126919

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:	3 Years to 17 Years
Genders Eligible for Study:	Both
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

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

No publications provided

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
Study First Received:	August 3, 2005
Last Updated:	February 8, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 09, 2012