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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00126932
Other study ID # 05-003
Secondary ID
Status Completed
Phase Phase 4
First received August 3, 2005
Last updated December 20, 2007
Start date October 2004
Est. completion date December 2004

Study information

Verified date December 2007
Source Connecticut Children's Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria:

- Ages 3-7, requiring venipuncture

Exclusion Criteria:

- Emergent procedure

- Allergy to lidocaine or sodium lauryl sulfate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
SonoPrep


Locations

Country Name City State
United States CT Children's Medical Center Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain associated with venipuncture
Secondary safety
Secondary skin effects
Secondary tolerability
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