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Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants

NCT00694174 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2008-06-10

No results posted yet for this study

Summary

The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. The study will also determine whether the use of sucrose (sugar water) when given by mouth has any effect on pain related skin blood flow changes.

Conditions

  • Procedural Pain

Interventions

DRUG

sucrose 24% oral solution

sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance

DRUG

sterile water

sterile water 2 ml single dose to be administered orally one time prior to heel lance

Sponsors & Collaborators

  • Children's Hospital of Michigan

    lead OTHER

Principal Investigators

  • Victoria Tutag Lehr, Pharm.D. · Children's Hospital of Michigan, The Detroit Medical Center, Wayne State University

  • Josef Cortez, M.D. · Hutzel Women's University Hospital, The Detroit Medical Center, Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00694174 on ClinicalTrials.gov