NCT00126919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Oct 2004

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

August 3, 2005

Last Update Submit

February 8, 2012

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • pain

Secondary Outcomes (2)

  • tolerability

  • safety-skin effects

Interventions

SonoPrepDEVICE

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 3-17 with subcutaneous port

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06040, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William T. Zempsky, MD

    CT Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pain Relief Program

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

October 1, 2004

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

US(1)