Reduction of Topical Anesthetic Onset Time Using Ultrasound | NCT00126932

Studies
Reduction of Topical Anesthetic Onset Time Using Ultrasound

NCT00126932

Sponsor

Connecticut Children's Medical Center

Status

Completed

Last Update Posted

Dec 27, 2007Estimated

Enrollment

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

Dec 2007

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

Not provided

Completion Date

Dec 2004

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

Dec 20, 2007

Last Update Posted Date

Dec 27, 2007Estimated

Description Module

Brief Summary

Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing 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

Name	Type	Description	Arm Group Labels	Other Names
SonoPrep	Device

Measure	Description	Time Frame
pain associated with venipuncture

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 3-7, requiring venipuncture

Exclusion Criteria:

Emergent procedure
Allergy to lidocaine or sodium lauryl sulfate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

7 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
CT Children's Medical Center		Hartford	Connecticut	06106	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

Measure	Description	Time Frame
safety
skin effects
tolerability