Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

• Sponsor: Connecticut Children's Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00126919
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2004
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. pain []

Secondary Outcome Measures

1. tolerability []

2. safety-skin effects []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 17 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center
• ClinicalTrials.gov Identifier: NCT00126919
• Other Study ID Numbers: 05-002
• First Posted: Aug 5, 2005
• Last Update Posted: Feb 9, 2012
• Last Verified: Feb 1, 2012

Study Results

No Results Posted as of Feb 9, 2012