NCT00126932

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Oct 2004

Shorter than P25 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
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
8 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
Last Updated

December 27, 2007

Status Verified

December 1, 2007

First QC Date

August 3, 2005

Last Update Submit

December 20, 2007

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • pain associated with venipuncture

Secondary Outcomes (3)

  • safety

  • skin effects

  • tolerability

Interventions

SonoPrepDEVICE

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 3-7, requiring venipuncture

You may not qualify if:

  • Emergent procedure
  • Allergy to lidocaine or sodium lauryl sulfate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CT Children's Medical Center

Hartford, Connecticut, 06106, 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
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

October 1, 2004

Study Completion

December 1, 2004

Last Updated

December 27, 2007

Record last verified: 2007-12

Locations

US(1)