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Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
This study has been completed.
Study NCT00694174   Information provided by Children's Hospital of Michigan
First Received: June 4, 2008   Last Updated: June 9, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 4, 2008
June 9, 2008
September 2005
skin blood flow response (perfusion units, PU) [ Time Frame: immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00694174 on ClinicalTrials.gov Archive Site
  • Heart rate [ Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 10 minutes prior to heel lance, 5 minutes after heel lance ] [ Designated as safety issue: Yes ]
  • Respiratory rate [ Time Frame: 10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance ] [ Designated as safety issue: No ]
  • axillary temperature [ Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance ] [ Designated as safety issue: Yes ]
  • oxygen saturation (SaO2) [ Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance ] [ Designated as safety issue: No ]
  • Neonatal Infant Pain Score [ Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance ] [ Designated as safety issue: No ]
Same as current
 
Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants

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.

During the last 25 years evidence that newborns can experience pain has been increasing. Painful procedures (injections, heel lances, and circumcisions) are part of normal routine newborn care. Studies have demonstrated that newborns have increased sensitivity to pain when compared with older children and adults. Pain assessment and management is an important component in the overall care of the newborn infant and safe, effective analgesics are needed. Pain assessment is complicated by the infants' verbal and cognitive limitations. Heart rate, blood pressure and oxygen saturation are commonly monitored in the nursery in response to pain, yet these parameters are affected by handling, illness, medications, as well as by pain. Skin blood flow has been documented to increase in premature newborns undergoing painful procedures in the Newborn Intensive Care Nursery. In the present study, Laser Doppler Imager technology will be used to define changes in skin blood flow response to heel lance and oral sucrose administration in normal newborn infants.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Procedural Pain
  • Drug: sucrose 24% oral solution
  • Drug: sterile water
  • Active Comparator: 2 ml sucrose 25% oral solution one time only dose by mouth
  • Placebo Comparator: sterile water 2 ml one time only dose given by mouth prior to heel lance

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
56
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent from parent or legal guardian.
  • Term, newborn infant, between 1 and 7 days of age.
  • Appropriate for gestational age (weight 5th through 95th percentile).

Exclusion Criteria:

  • Small or large for gestational age (weight<5th or >95th percentile).
  • Physical or biochemical abnormalities.
  • History of maternal drug dependence.
  • Apgar score <7 at 5 minutes.
  • Current use of analgesics.
Both
up to 7 Days
No
 
United States
 
 
NCT00694174
Victoria Tutag Lehr, Pharm.D., Children's Hospital of Michigan, The Detroit Medical Center
 
Children's Hospital of Michigan
 
Principal Investigator: Victoria Tutag Lehr, Pharm.D. Children's Hospital of Michigan, The Detroit Medical Center, Wayne State University
Principal Investigator: Josef Cortez, M.D. Hutzel Women's University Hospital, The Detroit Medical Center, Wayne State University
Children's Hospital of Michigan
June 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.