Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

NCT ID: NCT00126919

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-10-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SonoPrep

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children ages 3-17 with subcutaneous port

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

William Zempsky, MD

Director, Pain Relief Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William T. Zempsky, MD

Role: PRINCIPAL_INVESTIGATOR

CT Children's Medical Center

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

05-002

Identifier Type: -

Identifier Source: org_study_id