Hutzel Women's University Hospital, The Detroit Medical Center
Detroit, Michigan, 48201, United States
NCT Number: NCT00694174
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.
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All sexes
Interventional
Phase 4
Detroit, Michigan, 48201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance
Other names: Oral sucrose solution
sterile water 2 ml single dose to be administered orally one time prior to heel lance
Other names: sterile water U.S.P.
Time frame: immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)
Time frame: 10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance
Time frame: 10 minutes prior to heel lance, 5 minutes after heel lance
Time frame: 10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance
Time frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
Time frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
Time frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
Children's Hospital of Michigan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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