Reduction of Topical Anesthetic Time for Subcutaneous Por... | NCT00126919

Studies
Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

NCT00126919

Sponsor

Connecticut Children's Medical Center

Status

Completed

Last Update Posted

Feb 9, 2012Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Pain

Interventions

SonoPrep

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Aug 3, 2005

First Submission Date that Met QC Criteria

Aug 3, 2005

First Posted Date

Aug 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2012

Last Update Posted Date

Feb 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical CenterPrincipal Investigator

Lead Sponsor

Connecticut Children's Medical CenterOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
SonoPrep	Device

Measure	Description	Time Frame
pain

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children ages 3-17 with subcutaneous port

Exclusion Criteria:

Emergent need for port access
Allergy to lidocaine sodium lauryl sulfate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William T. Zempsky, MD	CT Children's Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Connecticut Children's Medical Center		Hartford	Connecticut	06040	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided