Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
- Conditions
- Procedural Pain
- Interventions
- Registration Number
- NCT00694174
- Lead Sponsor
- Children's Hospital of Michigan
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 sucrose 24% oral solution 2 ml sucrose 25% oral solution one time only dose by mouth 2 sterile water sterile water 2 ml one time only dose given by mouth prior to heel lance
- Primary Outcome Measures
Name Time Method skin blood flow response (perfusion units, PU) immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)
- Secondary Outcome Measures
Name Time Method Heart rate 10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance Blood pressure 10 minutes prior to heel lance, 5 minutes after heel lance Respiratory rate 10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance axillary temperature 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance oxygen saturation (SaO2) 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance Neonatal Infant Pain Score 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
Trial Locations
- Locations (1)
Hutzel Women's University Hospital, The Detroit Medical Center
🇺🇸Detroit, Michigan, United States