CClinicalTrials.gg
CompletedNCT00126919Updated Feb 9, 2012

Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

A Phase 4 interventional study of SonoPrep in Pain, sponsored by Connecticut Children's Medical Center. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2012-02-09.

Sponsored by Connecticut Children's Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
03

In context

Lead sponsor

Connecticut Children's Medical Center is the lead sponsor of 58 studies on the registry; 14 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children ages 3-17 with subcutaneous port

Exclusion criteria

Exclusion Criteria:

  • Emergent need for port access
  • Allergy to lidocaine sodium lauryl sulfate
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Interventions

  • DeviceSonoPrep
06

What researchers measure

Primary outcomes

  1. pain

Secondary outcomes

  1. tolerability

  2. safety-skin effects

07

Study locations

1 site
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06040, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00126919
Lead sponsor
Connecticut Children's Medical Center
Responsible party
William Zempsky, MD (Director, Pain Relief Program, Connecticut Children's Medical Center) — Principal investigator
First posted
Aug 5, 2005
Start date
Oct 2004
Primary completion
Oct 2006
Completion
Oct 2006
Last update
Feb 9, 2012

Study contacts

William T. Zempsky, MD
principal investigator · CT Children's Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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