Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00126919
First received: August 3, 2005
Last updated: February 8, 2012
Last verified: February 2012
  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
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:


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
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: 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 October 23, 2014