Procedural Pain Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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